CovidResearchTrials by Shray Alag


CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)


HP:0000726: DementiaHPO

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (7)


Name (Synonyms) Correlation
drug2856 Telephone interview Wiki 0.50
drug1258 Home Health Agency Care Wiki 0.50
drug2054 Paramedic Coaching Wiki 0.50
drug500 CAPABLE Transitions Wiki 0.50
drug953 ELISA and Rapid test to detect antibodies against COVID-19 Wiki 0.50
drug698 Cognitive Stimulation Wiki 0.50
drug968 Echocardiography Wiki 0.35

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D003704 Dementia NIH 1.00
D019965 Neurocognitive Disorders NIH 0.50
D060825 Cognitive Dysfunction NIH 0.32

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0001268 Mental deterioration HPO 0.32

There are 4 clinical trials

Clinical Trials


1 Community Paramedic Coaching Program for Caregivers and People With Dementia (CP3D)

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.

NCT04239924 Dementia Behavioral: Paramedic Coaching
MeSH:Dementia
HPO:Dementia

Primary Outcomes

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 months

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 average older adults.

Measure: Number of Visits to the Emergency Department by the Caregiver of the Person with Dementia

Time: up to 24 months

Description: 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 months

Description: 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 months

Secondary Outcomes

Description: 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 50

Description: 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 50

Description: 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 months

Description: 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 months

Description: 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)

2 Cognitive Outcomes During COVID-19 confiNemeNt in Elderly and Their Caregivers Using Technologies for DEMentia

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 414 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=2921), TV-AssistDem (N=100) and INFINITy (N=23) 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.

NCT04385797 Mild Cognitive Impairment Dementia Other: Telephone interview
MeSH:Dementia Cognitive Dysfunction
HPO:Cognitive impairment Dementia Mental deterioration

Primary Outcomes

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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

3 Care at 360º: A Long-term Individual Cognitive Stimulation Program for Older Adults With Neurocognitive Disorders, Non-Institutionalized and Socially Vulnerable

The 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.

NCT04417751 Neurocognitive Disorders Dementia Cognitive Impairment Cognitive Decline Cognitive Dysfunction Social Behavior Behavioral: Cognitive Stimulation
MeSH:Dementia Cognitive Dysfunction Neurocognitive Disorders
HPO:Cognitive impairment Dementia Mental deterioration

Primary Outcomes

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-intervention

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: Change in cognitive state evaluated through Mini-Mental State Examination

Time: 6 months after the beginning of the intervention

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: Change in cognitive state evaluated through Mini-Mental State Examination

Time: 12 months after the beginning of the intervention

Description: 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-intervention

Description: 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 intervention

Description: 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 intervention

Secondary Outcomes

Description: 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 intervention

Description: 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 intervention

Description: 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 intervention

Description: 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-intervention

Description: 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 intervention

Description: 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 intervention

Description: 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-intervention

Description: 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 intervention

Description: 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 intervention

Other Outcomes

Description: 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-intervention

Description: 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)]

4 A Randomized, Unblinded, 60-subject Three-wave Clinical Trial of an Occupational Therapy-led In-home Intervention Designed to Help Older Adults Successfully Transition to Their Homes Following a Skilled Nursing Facility Discharge

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.

NCT04460742 Care Transitions Dementia Behavioral: CAPABLE Transitions Behavioral: Home Health Agency Care
MeSH:Dementia
HPO:Dementia

Primary Outcomes

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 years

Description: 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 years

Description: The study will monitor the proportion of participants that complete the study.

Measure: Proportion of enrolled participants that are retained

Time: 6 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Secondary Outcomes

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 months

Description: 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 Months

Description: 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 Months


HPO Nodes


HP:0000726: Dementia
Genes 290
C9ORF72 HNRNPA2B1 DNAJC13 HTT CHCHD10 HNRNPA1 CLN6 FMR1 PSAP ATXN10 TOMM40 GBA ATXN3 PSEN1 ADH1C GBA2 CHMP2B COX1 TREM2 POLG NOTCH3 PLAU TRNF AARS2 PINK1 VPS13C TBP SYNJ1 MAPT ATXN8OS UCHL1 PSEN1 SNCA FUS TYMP SLC13A5 TRNC PLA2G6 MATR3 EPM2A SNCA C19ORF12 PANK2 SNCA CP PPP2R2B CHMP2B HTT TRNK TRNL1 ND1 ND4 PDGFB RRM2B NR4A2 ERCC8 MPO VPS13A LRRK2 SERPINI1 JPH3 PODXL GIGYF2 ITM2B WDR45 PRNP COX3 TRNQ DNMT1 SPAST SDHB ABCD1 C9ORF72 PRNP GBA PSEN2 NPC2 LRRK2 SQSTM1 GBA TRPM7 CYTB SNCA TRNV MAPT RNF216 HTRA1 COX3 COL4A1 CYP27A1 GRN FTL FMR1 TUBA4A TWNK APP ALDH18A1 MMACHC VPS13C MAPT MBTPS2 TMEM106B SQSTM1 ATP13A2 SPG21 ATN1 APTX GBA HEXA ATP6V0A2 PARK7 ALDH18A1 WDR45 DGUOK HTRA2 ARSA NOTCH2NLC TRNS2 ROGDI MAPT KCTD7 WFS1 TREM2 CISD2 TRNQ VPS35 APOE GBA PRNP PSEN2 HTT TBP HFE CLN3 NHLRC1 TRNS1 UBQLN2 GRN CHCHD10 PNPLA6 TRNH VCP SDHD HTRA1 TYROBP ZFYVE26 HNRNPA2B1 NPC1 TREM2 C9ORF72 SLC2A3 PSEN1 MAPT TYROBP TARDBP CP TREM2 PANK2 DNMT1 RNF216 PINK1 MATR3 ATP6V1A PLA2G6 SNCA SDHAF1 MAPT GRN CSF1R TTR XPR1 COX2 TRNF SDHA VCP SNCAIP SORL1 LRRK2 GRN ATXN2 TARDBP SCARB2 TRNW ATP7B APP GM2A PRDM8 TBK1 PDGFRB PRICKLE1 ATP13A2 IRF6 APOE ROGDI POLG PSEN1 ATXN2 CHMP2B PSEN1 APP PRKAR1B VCP ATP13A2 PRNP ITM2B ATP6 NHLRC1 ATP13A2 TBK1 TRNS2 ASAH1 NOS3 APP A2M EPM2A CSTB DNAJC5 COX1 CTSF CERS1 CHMP2B SQSTM1 WFS1 TRNW TUBB4A APP ATN1 PRNP ND5 C9ORF72 JPH3 SPG21 RAB39B PRKN ND6 MAPT ATXN2 DCTN1 ND5 ABCA7 APP SNCB CUBN PRNP PRNP FBXO7 ERCC4 HLA-DQB1 PSEN1 NDP C9ORF72 TREX1 DCTN1 PRDX1 PPP2R2B VCP TMEM106B SNCA CFAP43 PSEN1 VCP TRNE GBA2 APP NOTCH3 TRNS1 COX2 ATP6V1E1 TREM2 TIMM8A FTL VCP CHMP2B MAPT MECP2 ATP6 MAPT TMEM106B EIF4G1 DNM1L ND6 ADA2 ASAH1 GBE1 TRNL1 CST3 ND1 GLUD2 OPA1 DNAJC6
Protein Mutations 1
V158M
SNP 0