Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4876 | carotid-femoral pulse-wave velocity Wiki | 0.33 |
| drug4874 | care as usual Wiki | 0.33 |
| drug3835 | SPIRIT-in person Wiki | 0.33 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3836 | SPIRIT-remote Wiki | 0.33 |
| drug791 | COVID WHELD Wiki | 0.33 |
| drug1328 | Digital Health Online Platform Wiki | 0.33 |
| drug4883 | chlorine dioxide 3000 ppm Wiki | 0.33 |
| drug322 | Anthocyanins Wiki | 0.33 |
| drug3085 | Paramedic Coaching Wiki | 0.33 |
| drug1914 | Home Health Agency Care Wiki | 0.33 |
| drug1036 | Cognitive Stimulation Wiki | 0.33 |
| drug4873 | cardiovascular and respiratory systems monitoring Wiki | 0.33 |
| drug1312 | Dialectical Behavioral Therapy (DBT) Skills Wiki | 0.33 |
| drug205 | Acceptance and Commitment Therapy Wiki | 0.33 |
| drug2289 | LIVE Wiki | 0.33 |
| drug4884 | chloroquine Wiki | 0.33 |
| drug4893 | community health worker support Wiki | 0.33 |
| drug4889 | clinical features and laboratory values Wiki | 0.33 |
| drug4323 | Telephone interview Wiki | 0.33 |
| drug1327 | Digital Health Literacy Intervention Wiki | 0.33 |
| drug736 | CAPABLE Transitions Wiki | 0.33 |
| drug5230 | standard care Wiki | 0.17 |
| drug4597 | Usual care Wiki | 0.15 |
| drug3195 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003704 | Dementia NIH | 1.00 |
| D019965 | Neurocognitive Disorders NIH | 0.24 |
| D060825 | Cognitive Dysfunction NIH | 0.22 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0001268 | Mental deterioration HPO | 0.22 |
| HP:0001677 | Coronary artery atherosclerosis HPO | 0.11 |
Navigate: Correlations HPO
There are 9 clinical trials
The proposed study will adapt and pilot test an efficacious advance care planning interventions, SPIRIT (Sharing Patient's Illness Representations to Increase Trust), with patients with mild dementia and their surrogates to promote open, honest discussions while such discussions about end-of-life care are possible. The study includes two phases: Phase I to adapt, pretest, and refine SPIRIT, and Phase II to pilot test the refined SPIRIT to formally evaluate its feasibility, acceptability, and preliminary efficacy. The final products will be the modified SPIRIT intervention that improves dementia patient and surrogate outcomes, and standardized intervention manuals, including the SPIRIT Interview Guide, fidelity assessment, and training materials. Patient and surrogate decision maker dyads will participate in a single SPIRIT session and will then have a follow up phone call 2-3 days later. One year after the SPIRIT session some surrogates will be contacted to provide additional feedback about the intervention.
Description: Dyad congruence will be assessed using the Goals-of-Care Tool which has been modified to include two scenarios relevant to the context of dementia. There are three response options: "The goals of care should focus on delaying my death no matter what, and thus I want to continue life-sustaining treatment", "The goals of care should focus on my comfort and peace, and thus I do not want life-sustaining treatment", and "I am not sure". Patients and surrogates complete this tool independently and their responses are then compared to determine dyad congruence (either congruent in both scenarios or incongruent). If both members of the dyad endorse "I am not sure", they are considered incongruent.
Measure: Change in dyad congruence among Phase II participants Time: Baseline, follow up phone call (2-3 days post-intervention)Description: Surrogate decision-making confidence will be measured using the 5-item Decision Making Confidence (DMC) scale. DMC assesses a surrogate's confidence in knowing the patient's wishes, ability to make treatment decisions even in a highly stressful situation, ability to seek information about risks and benefits of medical choices, ability to handle unwanted pressure from others, and ability to communicate with providers about the patient's wishes. Surrogates indicate how confident they are about making medical decisions, if the patient becomes unable to make their own decisions, by their level of agreement with statements along a scale of (0) "not confident at all" to (4) "Very confident". Total scores range from 0 - 20, with higher scores indicating greater confidence.
Measure: Change in Surrogate's Decision Making Confidence (DMC) scale score among Phase II participants Time: Baseline, follow up phone call (2-3 days post-intervention)Description: The Overall Preparedness Scale for end-of-life decision making for surrogates is a 21-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 21 to 84, with higher scores indicating higher levels of preparedness.
Measure: Change in Surrogate's Overall Preparedness Scale Time: Baseline, follow up phone call (2-3 days post-intervention)Description: Medical records will be reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there is no documentation, the surrogate will be contacted to get confirmation on the status of the Advance Directive.
Measure: Completion of Advance Directives among Phase I participants Time: 12 months post-interventionDescription: Medical records will be reviewed to determine if the patient completed an advance directive (a medical power of attorney or living will) by 12 months post-intervention. If there is no documentation, the surrogate will be contacted to get confirmation on the status of the Advance Directive.
Measure: Completion of Advance Directives among Phase II participants Time: 12 months post-interventionDescription: The Overall Preparedness Scale for end-of-life decision making for patients is a 20-item investigator-developed measure. The measure assesses the level of preparedness for end-of-life decision making in the cognitive, emotional, and behavioral dimensions on a 4-point scale (1=strongly disagree to 4=strongly agree). Total scores range from 20 to 80, with higher scores indicating higher levels of preparedness.
Measure: Change in Patient's Overall Preparedness Scale Time: Baseline, follow up phone call (2-3 days post-intervention)The aim of this project is to study the safety and efficacy of anthocyanins in improving key dementia-related mechanisms and cognitive functioning in older people at risk for dementia. Secondary analyses will include a variety of biological measures, including biochemistry, imaging and cardiovascular measures.
Description: A composite measure from the CogTrack battery
Measure: Quality of episodic memory. Time: Baseline to 24 weeksDescription: CogTrack evaluates attentional intensity index, sustained intensity index, cognitive reaction time, attentional fluctuation index, quality of working memory, quality of episodic memory and speed of memory retrieval.
Measure: Secondary endpoints from CogTrack Time: Baseline to 24 weeksDescription: Lipid profile, fatty acids, cytokines ( among others: IL-1, IL-2, IL-6, TNF-a), plasma antoxidant status and vitamins (lipid peroxidation markers, vitamins E, C, A, total plasma antioxidant capacity, glutathion)., carinthine, blood glucose, HbA1c, anthocyanins and metabolites, mapping of a-beta degradation products.
Measure: Blood outcome analysis Time: Baseline to 24 weeksDescription: Flow-mediated dilation (FMD), Cardiac-ankle vascular index (CAVI), photoplethysmogram (PPG).
Measure: Cardiovascular parameters Time: Baseline to 24 weeksDescription: Microbiota
Measure: Fecal analysis Time: Baseline to 24 weeksDescription: kyrinin
Measure: Urine analysis Time: Baseline to 24 weeksDescription: anthocyanin metabolites
Measure: CSF measurements Time: Baseline to 24 weeksDescription: Diagnosing and follow-up of cerebrovascular disease
Measure: MR-imaging/CT Time: Baseline to 24 weeksThis study aims at developing, implementing and evaluating a complex intervention involving Learning, Innovation, Volunteers and Empowerment for home dwelling persons with dementia and their caregivers. The investigators hypothesise that a successfully implemented intervention will reduce caregivers burden and be cost-effective.
Description: RUD:A validated tool for assessment of time use for cost effectiveness analyses, measuring total time use in hours/day for different activities, numbers of contact points with care professionals and use of medications, high time use, many contacts and many medications indicates high resource use
Measure: Resource Utilization in Dementia Time: up to 24 months follow up, assesment every 6 monthsDescription: RSS: measuring caregiver distress, 15 items ranging from 0-4, high score indicates high burden
Measure: Relative stress scale Time: up to 24 months follow up, assessment every 6 monthsDescription: I-ADL scale assessing instrumental activities such as use of telephone, economy, household, public transport and shopping, range from 8-31, higher score indicates poorer functioning
Measure: Activities of daily living, instrumental Time: 24 months follow up, assesment every 6 monthsDescription: CSDD: Cornell scale for depression in dementia, range 0-38, high score indicates high symptom load
Measure: Depression and mood Time: 24 months follow up, assesment every 6 monthsDescription: CMAI: Cohen-Mansfield Agitation Inventory, 29 items assessing the frequency of agitated behaviour, range 29-203, high score indicates higher severity
Measure: Agitation Time: 24 months follow up, assesment every 6 monthsDescription: NPI: presence, severity and burden of depression, anxiety, psychosis and motor disturbances, range from 0-144, high score indicates frequent, severe and burdensome symptoms
Measure: Neuropsychiatric symptoms Time: 24 months follow up, assesment every 6 monthsDescription: Falls, disappearances outdoor, admissions to acute wards, fire hazard
Measure: Adverse events Time: 24 months follow up, assesment every 6 monthsDescription: number of technical aids, cognitive intervention devices and assisted-living systems
Measure: Use of assistive technology Time: 24 months follow up, assesment every 6 monthsDescription: number of participants with contact with a volunteer, number of hours spent with volunteer
Measure: Use of volunteers Time: 24 months follow up, assesment every 6 monthsDescription: P-ADL, assessing personal activities such as toileting, grooming, dressing, transfer and eating, scale range 6-30, higher score indicates poorer personal functioning
Measure: Activities of daily living, personal Time: 24 months follow up, assesment every 6 monthsDescription: EQ-5D-5L, Descriptive measure of health related quality of life comprising 5 Dimensions With 5 Levels each, scores can be converted to a single summary index number
Measure: Quality of Life Time: 24 months follow up, assesment every 6 monthsDescription: EQ-5D, Descriptive measure of quality of life rated on a VAS scale range 0-100, high score indicates good health
Measure: Quality of Life VAS scale Time: 24 months follow up, assesment every 6 monthsDescription: QoL-AD: Quality of life in Alzheimer dementia, 13 items likert scale, range from 13-52 points, high score indicates high quality of life
Measure: Quality of Life Time: 24 months follow up, assesment every 6 monthsDescription: number of hours spent with a volunteer
Measure: Use of volunteers Time: 24 months follow up, assesment every 6 monthsDescription: Clinical global impression of change, to quantify and track patient progress and treatment response on a scale from 1 to 7, at which 7 indicates substantial worsening.
Measure: Change achieving Time: at the start of intervention, and every 6 monthsDescription: GDS: Geriatric depression scale, 30 items rated yeas or no, high score indicates high burden
Measure: Caregiver depression Time: 24 months follow up, assesment every 6 monthsDescription: GMHR: General medical health rating scale, 4 point likert scale, range from 1-4, high score indicates high comorbidity burden
Measure: Comorbidity Time: 24 months follow up, assesment every 6 monthsDescription: MOBID-2: assesses the intensity of pain based on interpretation of pain related behaviour, range from 0-10, high score indicates high pain intensity
Measure: Pain in dementia Time: 24 months follow up, assesment every 6 monthsDescription: IQ CODE: Proxy rater instrument for assessment of change in cognitive performance the last 10 years, range 16-80, high score indicates great decline
Measure: Change in cognitive performance Time: BaselineDescription: Self and proxy reported use of medications, both regular and on demand
Measure: Medication use Time: At the start of the intervention, and every 6 onth follow upDescription: Participation in educational programes, both for persons with dementia and for caregivers.
Measure: Participation in educational programs Time: 24 months follow up, assessment every 6 monthsDescription: Caregivers perception of risk of contamination With Sars-Cov-10
Measure: COVID-19: risk perception Time: month 6 to month 12 (during COVID-19 lock down in Norway)Description: Change in services and contact due to restrictions of COVID-19
Measure: COVID-19: restrictions Time: month 6 to month 12 (during COVID-19 lock down in Norway)Description: Caregivers perception of caregiver burden during COVID-19
Measure: COVID-19: caregiver burden Time: month 6 to month 12 (during COVID-19 lock down in Norway)Description: NPI: change in presence, severity and burden of depression, anxiety, psychosis and motor disturbances
Measure: COVID-19: neuropsychiatric symptoms Time: month 6 to month 12 (during COVID-19 lock down in Norway)Description: CSDD: Change in cornell scale for depression in dementia.
Measure: COVID-19: depression and mood Time: month 6 to month 12 (during COVID-19 lock down in Norway)This pilot study is designed to evaluate the potential effectiveness of the implementation strategy and intervention delivery model of a community paramedic coaching program for caregivers of persons with dementia, in direct coordination with the participant and caregiver's primary health care team. Specifically, the acceptability, appropriateness, and feasibility of the program will be assessed, collecting data from all implementation stakeholders at baseline, 13 weeks, 25 weeks, and post-intervention (~50 weeks) using quantitative survey instruments and qualitative interviews.
Description: As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for persons with dementia.
Measure: Number of Visits to the Emergency Department by the Person with Dementia Time: up to 24 monthsDescription: As determined by abstracting the medical records, the investigators are testing the hypothesis that the number of visits to the Emergency Department is lower than commonly reported in the literature for average older adults.
Measure: Number of Visits to the Emergency Department by the Caregiver of the Person with Dementia Time: up to 24 monthsDescription: The intervention will be deemed feasible if at least 75% of the intended coaching phone calls are completed. The minimum number of coaching calls is 3, additional calls will be scheduled opposite weeks of home visits as needed.
Measure: Feasibility: Proportion of Coaching Phone Calls Completed Time: up to 12 monthsDescription: The intervention will be deemed feasible if at least 75% of the intended home visits are completed. The minimum number of intended home visits is 9.
Measure: Feasibility: Proportion of Coaching Home Visits Completed Time: up to 12 monthsDescription: The Zarit Burden Interview measures caregiver burden. This is a 12-item survey with a total possible range of scores from 0-48, where higher scores indicate increased burden. The investigators hypothesize the score will decrease as a result of the intervention.
Measure: Change in Zarit Burden Interview (ZBI-12) Score Time: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)Description: The GAD-7 is a 7-item survey that measures anxiety symptom severity. The total possible range of scores is 0-21, where higher scores indicate increased symptom severity. The investigators hypothesize the score will decrease as a result of the intervention.
Measure: Change in Generalized Anxiety Disorder (GAD-7) Score Time: Baseline, week 13, week 25, week 50Description: The CESD-10 is a general measure of depression frequently used in caregiver studies. It is a 10-item survey with a total possible range of scores of 0-30 where higher scores indicate increased depression. The investigators hypothesize the score will decrease as a result of the intervention.
Measure: Change in Center for Epidemiologic Studies Depression Scale (CESD-10) Time: First home visit (~ week 1), week 13, week 25, and last home visit (~up to week 50)Description: The RCSS is a 6-item survey used to measure the positive aspects of caring. The range of total possible scores is 6-30 where higher scores indicate increased caregiver satisfaction. The investigators hypothesize the score will increase as a result of the intervention.
Measure: Change in Revised Caregiving Satisfaction Scale (RCSS) Time: Baseline, week 13, week 25, week 50Description: The revised scale for caregiving self-efficacy measures three domains: obtaining respite, responding to disruptive patient behaviors, and controlling upsetting thoughts. It is a 15-item scale with a total possible range of scores between 0-100, where higher scores are better. The investigators hypothesize the score will increase as a result of the intervention.
Measure: Change in Revised Scale for Caregiving Self-Efficacy Time: First home visit (~ week 1) and last home visit (~up to week 50)Description: WFC is measured for the caregiver. It is a 6-item survey with a total possible range of scores between 6-30 with higher scores indicating lesser work-family conflict. The investigators hypothesize the score will increase as a result of the intervention.
Measure: Change in Work-Family Conflict Scale (WFC) Time: First home visit (~ week 1) and last home visit (~up to week 50)Description: C-DEMQOL is measured for the caregiver. The investigators will be asking 18 of the questions from the scale to understand the quality of life the caregivers experience. Scores can range from 18-90, with a higher score reflecting a higher quality of life.
Measure: Change in Caregiver Quality of Life (C-DEMQOL) Score Time: Baseline and 62 weeks (12 weeks post completion)Description: DKAS is measured for the caregiver. It is a 25 item true-false survey of facts about dementia. Scoring is by measuring the proportion of questions answered correctly.
Measure: Change in Knowledge of Dementia (DKAS) Score Time: Baseline and 62 weeks (12 weeks post completion)Description: As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for persons with dementia.
Measure: Clinic Utilization by Persons with Dementia Time: up to 24 monthsDescription: As determined by abstracting the medical records, the investigators are characterizing the number of contacts with outpatient clinics for caregivers of persons with dementia.
Measure: Clinic Utilization by Caregivers of Persons with Dementia Time: up to 24 monthsDescription: Assesses caregivers perception of communication with health care team and extent to which the team considers their capacity and preferences in decision making. This measure consists of 12 questions, with scores ranging from 12-60, where higher scores indicate increased communication with the health care team.
Measure: Change in Caregiver Perceptions About Communication With Clinical Team Members (CAPACITY) Measure Time: Baseline and 62 weeks (12 weeks post completion)Coronavirus disease 2019 has forced worldwide the implementation of unprecedented restrictions to control its rapid spread and mitigate its impact. The Spanish government has enforced social distancing, quarantine and home confinement. This restriction of daily life activities and separation from loved ones may lead to social isolation and loneliness with health-related consequences in community-dwelling older adults with mild cognitive impairment or mild dementia and their caregivers. Additionally, an inadequate access to healthcare and social support services may aggravate chronic conditions. Technology home-based interventions emerge for combating social isolation and loneliness preventing the risk of viral exposure. The aim of this multicentre cohort study is to explore, analyze and determine the impact of social isolation on: 1) cognition, quality of life, mood, technophilia and perceived stress of community-dwelling older adults with mild cognitive impairment or mild dementia, and on caregiver burden; 2) health and social care services access and utilization, and 3) cognitive, social and entertainment use of ICTs. This study will be conducted in two Spanish regions Andalucía (Málaga) and Cataluña (Tarrasa). In total 200 dyads, consisting of a person with mild cognitive impairment or mild dementia (PMCI/MD) and their informal caregiver will be contacted by telephone. Potential respondents will be participants of the SMART 4 MD (N=100) and TV-AssistDem (N=100) clinical trials. The change in means in the variables will be analyzed comparing baseline results in the previous studies with those during and after confinement using the ANOVA test of repeated measures or the non-parametric Friedman test if appropriate. The performance of a multivariate analysis of variance (ANCOVA) to introduce possible covariates will also be contemplated. A 95% confidence level will be used.
Description: The Mini-Mental State Examination (MMSE) (23) will be used to assess the cognitive function of the PMCI/MD. The most common cutoff scores for cognitive impairment and dementia are ranging 23 to 27 over 30. As telephone call interviewing will be the safest means to communicate with the PMCI/MD during and after the COVID-19 pandemic the 22 items telephone version of the MMSE will be used (24). All points of the MMSE can be covered in the telephone version except the last section assessing language and motor skills. In the phone version, we will ask the subject to repeat a phrase and name one item (For example: "Tell me, what is the name of the object you are using to talk to me?"). However, a second item will be not be named, nor will be the person be asked to follow a three-stage command, read and obey a sentence, write a sentence, or copy an intersecting pentagon as in the original version.
Measure: Change on cognitive function in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Quality of Life-Alzheimer's Disease Scale (QoL-AD) (19-22) is an instrument specifically designed to measure QoL in PMCI/MD from the perspective of both the patient and the informal caregiver. It is a 13-item measure, which includes assessments of the person´s relationships with friends and family, financial situation, physical condition, mood, memory, and an overall assessment of life quality. Response are 4-point multiple choice options (1 = poor, 2= fair, 3= good, 4 = excellent). Scale scores range from 13 to 52, with higher scores indicating greater quality of life. When cognitive function may be compromised, informal caregivers will complete the QoL-AD, on behalf of the PMCI/MD.
Measure: Change on quality of life in Alzheimer´s Disease in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The European Quality of Life 5 Dimensions 3 Levels (EuroQoL-5D-3L) is a standardized generic instrument consisting of a descriptive system and a visual analogue scale (VAS). The descriptive system comprises 5 dimensions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, moderate problems and extreme problems. A 1-digit number expresses the level selected for that dimension. The digits can be combined into a 5-digit number that describes the patient's health state. The VAS records the patient's self-rated health on a vertical scale, where the endpoints are 100 = 'The best health you can imagine' and 0 = 'The worst health you can imagine'. EuroQoL-5D-3L has been shown to correlate well with QoL-AD, indicating that using both measures side-by-side is compatible.
Measure: Change on quality of life in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Short Form of the Geriatric Depression Scale (GDS) (25) will be used to assess mood. Of the 15 items, 10 indicate depression when answered positively, while the rest (1, 5, 7, 11, 13) when answered negatively. Scores of 0-4 are considered normal, 5-8 indicate mild depression, 9-11 moderate depression, and 12-15 severe depression.
Measure: Change on mood in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Instrument for Measuring Older People's Attitudes Toward Technology (TechPH) measures older people's attitudes and enthusiasm for health technology (26). This instrument refers to technophilia as a person's enthusiasm for and positive feelings toward their technology use and absence of the fears and doubts some older people could have about their ability to manage using new technology. The six items of the instrument measure two factors of technophilia: 3 items concerning techEnthusiasm and 3 items techAnxiety. Response are constructed with a five-point Likert scale questionnaire, ranging from 1 (fully disagree) to 5 (fully agree).
Measure: Change on technophilia in people with mild cognitive impairment or mild dementia prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Perceived Stress Scale (PSS) measures the degree to which situations in one's life are appraised as stressful. The scale has 10 questions regarding feelings and thoughts during the last month and are rated according to frecuency 0 = Never 1 = Almost Never 2 = Sometimes 3 = Fairly Often 4 = Very Often. PSS scores are obtained by reversing responses (e.g., 0 = 4, 1 = 3, 2 = 2, 3 = 1 & 4 = 0) to the four positively stated items (items 4, 5, 7, & 8) and then summing across all scale items
Measure: Change on perceived stress in people with mild cognitive impairment or mild dementia during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Zarit Burden Interview (ZBI-12) is a 12-item scale with each answer chosen from a 5-point Likert scale (Nearly always=4, Quite frequently=3, Sometimes=2, Rarely=1, Never=0). It is a shortened version of the original scale, was developed specifically for informal caregivers of PMCI/MD and covers issues such as caregiver stress and the degree to which caring is affecting their health and social life. Total score range 0 to 48 (0-10= no to mild burden, 10-20= mild to moderate burden >20= high burden).
Measure: Change on caregiver burden prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: The Client Service Receipt Inventory (CSRI) (32,33) scale will be used to evaluate the service utilization. This scale is an internationally used method for gathering data on service utilization and other domains relevant for economic analysis of mental health care. It has five sections: background client information, accommodation and living situation, employment history, earnings and benefits, a record of services usually used and information about informal caregiver support. The sections assessed will be consultations, admissions and visits, grouped into subsections according to hospital, specialist, primary or home care. Treatment related to hospital admissions or illness exacerbation will also be assessed. It´s adaptability ensures it is compatible with the research aims, context, participants' likely circumstances, and the quantity and precision of information required.
Measure: Change on healthcare and social support services access prior to, during and after confinement. Time: Through study completion, an average of 6 monthsDescription: Use of ICTs (SmartPhone, Tablet, Computer, Smart-TV, or other) to contact healthcare and social support services, to stimulate cognition, to facilitate social connectedness (telephone call, video call, texting...), to access COVID-19 information and to enable entertainment.
Measure: Change from health, cognitive, social, informative and entertainment related uses of ICT during and after confinement. Time: Through study completion, an average of 6 monthsThe aim of the intervention proposed in the present study is to assess the effect of a cognitive stimulation (CS) intervention program in an individual and long-term format, for non-institutionalized elderly people with neurocognitive disorders and in a situation of social vulnerability. Specifically, to test the effectiveness of CS on the global cognitive state, on mood state, on quality of life and on functional state. The program will be composed by 50 sessions, including three of assessment sessions (pre, intra and post-intervention). Each session will have a duration of 45 minutes with a weekly frequency. Control group participants will maintain their treatment as usual.
Description: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Cognitive state evaluated through Mini-Mental State Examination Time: Pre-interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Mini-Mental State Examination is a brief screening test for cognitive function. Assesses 6 cognitive functions: orientation, registration, attention and calculation, recall, language and visuoconstructive ability. Global score ranges from 0-30 points, higher scores indicate better cognitive function.
Measure: Change in cognitive state evaluated through Mini-Mental State Examination Time: 12 months after the beginning of the interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Cognitive performance evaluated through Montreal Cognitive Assessment Time: Pre-interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 6 months after the beginning of the interventionDescription: It's a 32-item mild cognitive impairment screening instrument that assesses eight cognitive functions: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall and orientation. Montreal Cognitive Assessment score is calculated by adding the points of the tasks successfully completed, and it ranges from 0 to 30 points, being that higher scores indicate better cognitive performance.
Measure: Change in cognitive performance evaluated through Montreal Cognitive Assessment Time: 12 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Depressive symptoms evaluated through Geriatric Depression Scale -15 Time: Pre interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention, intra-intervention and postintervention assessments. Geriatric Depression Scale -15 is a screening test for depressive symptoms in elderly adults. Assesses depression in the elderly by distinguishing between depressive and dementia symptoms. This instrument does not include somatic conditions common to the elderly, such as appetite, sleep or sexual disturbances, or lower energy level. The overall score ranges from 0 to 15. The higher the score, the greater the severity of the depressive symptoms.
Measure: Change in depressive symptoms evaluated through Geriatric Depression Scale -15 Time: 12 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: Pre-interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 6 months after the beginning of the interventionDescription: Significant statistic improvement in the participant's test scores between pre-intervention assessment and postintervention assessment. Quality of Life - Alzheimer's Disease is an instrument to assess quality of life in people diagnosed with dementia, gathering information from the patient and the caregiver. It is composed by 13 items regarding perception of health, mood, functional abilities, interpersonal relationships and hobbies, decision making ability and life in general. It has good psychometric characteristics and it's use has been recommended to evaluate psychosocial interventions. Scores range between 13 - 52 points. Higher scores indicate better quality of life.
Measure: Change in quality of life evaluated through Quality of Life - Alzheimer's Disease: score Time: 12 months after the beginning of the interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: Pre-interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 6 months after the beginning of the interventionDescription: It's an instrument that assesses the independence level of the elderly people regarding IADL's. A score is assigned according to the person's ability to perform a given task. A set of three, four or five options is suggested for each question, which is scored from 1 to 3, 1 to 4 or 1 to 5 points. The highest score corresponds to a greater degree of dependency. If a task does not apply because the person did not perform it in the pre-morbid period, the score for that task is not included in the total score, that is, the maximum possible score includes only the maximum scores of the tasks that the person performed. The score ranges from 8 to 30 points (a score of 8 points means that th person is independent; between 9 and 20 points means a moderate dependency; greater than 20 points means severe dependency).
Measure: Change in functional status is assessed using the Lawton and Brody Instrumental Activities of Daily Living. Time: 12 months after the beginning of the interventionDescription: Sociodemographic data will be collected using a sociodemographic questionnaire, designed specifically for this study, regarding information about age, gender, literacy, health conditions, among others.
Measure: Sociodemographic data collected through a sociodemographic questionnaire Time: Pre-interventionDescription: Adherence to the intervention and dropouts will be assessed using a session form, designed specifically for this study, completed by the technician after each session, regarding the attendance and mood/behavior of the participants throughout the intervention sessions.
Measure: Adherence to the intervention and dropouts evaluated through a session form Time: [Pre, intra (6 months) and post intervention (12 months)]This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from the skilled nursing facility to home as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a skilled nursing facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.
Description: The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Measure: Proportion of participants screened as eligible Time: Through study completion, an average of 3 yearsDescription: The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
Measure: Proportion of screened participants that enroll Time: Through study completion, an average of 3 yearsDescription: The study will monitor the proportion of participants that complete the study.
Measure: Proportion of enrolled participants that are retained Time: 6 monthsDescription: Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Measure: Proportion of participants who perceive a benefit from the intervention Time: 3 monthsDescription: Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Measure: Proportion of participants who perceive a benefit from the intervention Time: 6 monthsDescription: The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.
Measure: Proportion of Critical Tasks Completed Time: Throughout Study Intervention, an average of 5 monthsDescription: The study will monitor the proportion of participants who have complete information on home time, quality of life, and health services utilization at 3 months.
Measure: Data Completeness on Clinical Outcomes Time: 3 monthsDescription: The study will monitor the proportion of participants who have complete information on home time, quality of life, and health services utilization at 6 months.
Measure: Data Completeness on Clinical Outcomes Time: 6 monthsDescription: Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time at 3 months of follow-up.
Measure: Home Time in Days Time: 3 monthsDescription: Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time at 6 months of follow-up.
Measure: Home Time in Days Time: 6 monthsDescription: The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up. Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome. The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' out of 100. Therefore higher scores may indicate better outcomes.
Measure: Mean change in quality of life using EQ-5D-5L (unabbreviated title) Time: 3 monthsDescription: The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up. Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome. The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine' out of 100. Therefore higher scores may indicate better outcomes.
Measure: Mean change in quality of life using EQ-5D-5L (unabbreviated title) Time: 6 monthsDescription: The study will examine the proportion of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility within 3 months of follow-up. The study also will tabulate the mean number of times they used these services within 3 months of follow-up.
Measure: Health Services Use Time: 3 MonthsDescription: The study will examine the proportion of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility within 6 months of follow-up. The study also will tabulate the mean number of times they used these services within 6 months of follow-up.
Measure: Health Services Use Time: 6 MonthsMore than 400,000 people in the UK live in care homes. These individuals are particularly vulnerable to COVID-19; many are frail and the majority have concurrent physical health problems and dementia. This group are at the highest risk of becoming severely ill with COVID-19 and are dependent on a stretched care workforce. The isolation, together with the stresses and distressing nature of the current work environment is also likely to have an impact on the mental health and well-being of care staff. It is vital to provide good quality support to enable care staff to remain resilient, and to enable good quality care that maintains the well-being of residents with dementia and reduces emerging neuropsychiatric symptoms in residents without increasing harmful sedative medications. COVID E-WHELD is based on the optimized WHELD training intervention on successfully completed in randomised clinical trials (RCTs) in 86 care homes, more than 1000 people with dementia. WHELD reduced use of anti-psychotics, improved agitation and overall neuropsychiatric symptoms, improved quality of life and reduced mortality for people with dementia. A digital version of WHELD (eWHELD) with virtual supervision in a further care home RCT including 130 people with dementia has demonstrated benefits for staff carers and improvements in the quality of life of people with dementia, with eWHELD combined with virtual supervision, but not with e-learning alone. The current project will evaluate a COVID-19 adapted version of eWHELD to address current needs of care homes during the COVID-19 pandemic. This will be undertaken in a 2 arm, 4 month, randomized cluster RCT in 1280 care homes (allowing for 75% drop out with COVID-19 outbreaks) to determine whether COVID-19 adapted eWHELD improves quality of life and mental health for people with dementia in care homes and the mental health of care staff.
Description: Validated quality of life measure for people with dementia, assessed by informant interview. Minimum score = 32 Maximum score = 128; Higher score denotes better outcome.
Measure: Dementia Quality of Life - DEMQOL proxy Time: 4 monthsDescription: Standardized assessment of neuropsychiatric symptoms in people with dementia, assessed by informant interview. Minimum score = 0 Maximum score = 144; Higher score denotes worse outcome.
Measure: Neuropsychiatric Inventory Time: 4 monthsDescription: Use of antipsychotic and other psychotropic medications from prescribing charts
Measure: Psychotropic medications Time: 4 monthsDescription: Staff confidence measure, self completed questionnaire. Minimum score = 9 Maximum score = 45; Higher score denotes better outcome.
Measure: Confidence in Dementia (CODE) Scale Time: 4 monthsDescription: Perceived self efficacy of care staff, self completed questionnaire. Minimum score = 17 Maximum score = 68; Higher score denotes better outcome.
Measure: Sense of Competence in Dementia Care Staff (SCIDS) scale Time: 4 monthsDescription: Mental Health of care staff, self reported questionnaire. Minimum score = 0 Maximum score = 27; Higher score denotes worse outcome.
Measure: Patient Health Questionnaire (PHQ-9) Time: 4 monthsDescription: A standardized instrument for measuring generic health related quality of life, used for Health economic evaluation. Visual Analogue scale minimum score = 0, maximum score = 100. Higher score denotes better outcome.
Measure: EQ5D (Euroquol 5D - 5 dimensions) Time: 4 monthsDescription: to collect service utilization data for health economics. Assesses cost of service provision; as such no min/max values. Higher value denotes worse cost outcome.
Measure: Client Service Receipt Inventory Time: 4 monthsDescription: Ordinal scale to rate progress towards personalized goals for people with dementia as a process outcome. Scale for each goal: Minimum score = 1 Maximum score = 4; Higher score denotes better outcome.
Measure: Goal Attainment Scaling Time: 4 monthsDementia is a condition that causes cognitive decline beyond normal ageing. Anxiety and depression are very common in people with dementia, but their needs are often under-recognised and under-served. Acceptance and Commitment Therapy (ACT) can reduce anxiety and depression by increasing psychological flexibility, the ability to pursue a meaningful life, in spite of unpleasant thoughts or feelings. There is much to learn about if and how ACT works for people with dementia, and whether it could be an effective psychological therapy for this population. Three participants with a dementia diagnosis and clinically-significant levels of anxiety and/or depression will be identified by their GP or Memory Assessment Service (MAS) in Nottinghamshire. Participants will attend 12 weekly, 90-minute sessions of ACT with the Principal Investigator (PI), accompanied by their caregiver if they so wish. In session, participants will complete several short questionnaires to measure their anxiety and depression, goals for therapy, psychological flexibility and relationship with the therapist. One week after the final session, an independent researcher will meet with participants and their carers to discuss their opinions of therapy and any changes to their anxiety and/or depression. One and three months after therapy, participants will be sent two short questionnaires to measure their current anxiety and depression. Information gathered from the independent researcher and questionnaires will be used to develop a case record for each participant, which will be looked at by independent psychotherapy experts to see whether ACT was effective. This research is being funded by Health Education England and is expected to last one year in total. Participant duration will last about 7 months. The study will form a Doctoral Thesis at the University of Nottingham and will be submitted to a peer-reviewed journal for distribution.
Description: Generalised anxiety disorder questionnaire (GAD-7), scored 0-21, where higher scores indicate a greater severity of anxiety.
Measure: Change in anxiety Time: Through study completion, up to 24 weeksDescription: Patient health questionnaire (PHQ-9), scored 0-27, where higher scores indicate a greater severity of depression.
Measure: Change in depression Time: Through study completion, up to 24 weeksDescription: Comprehensive assessment of Acceptance & Commitment Therapy (CompACT-SF), scored 0-48, where higher scores indicate increased psychological flexibility.
Measure: Change in psychological flexibility Time: Through study completion, up to 24 weeksDescription: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS), scored 7-35, where higher scores indicate higher mental wellbeing.
Measure: Change in wellbeing Time: Through study completion, up to 24 weeksDescription: Personal questionnaire (PQ), where higher scores indicate greater severity of problems.
Measure: Change in client problems Time: Through study completion, up to 24 weeksDescription: Session rating scale (SRS), does not involve numerical values but asks clients to mark on a line nearest to the description that best fits their experience (marks further towards the right indicate better therapeutic alliance).
Measure: Change in therapeutic alliance Time: Through study completion, up to 12 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports