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 (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug431 | Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally Wiki | 1.00 |
| drug1362 | Telephone interview Wiki | 1.00 |
| drug1285 | Standard of care Wiki | 0.28 |
There is one clinical trial.
Clinical Trials
1 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
HPO Nodes
HP:0000726: Dementia
Genes 277
FUS PSEN2 MBTPS2 PLA2G6 HEXA C9ORF72 HTT ND5 ATXN10 SNCAIP MAPT TRNS2 TWNK GBA POLG JPH3 NOTCH3 APOE TMEM106B GM2A PSEN1 APP COL4A1 MECP2 PRKN DNMT1 POLG PRDX1 CISD2 GRN TREM2 COX3 GRN SNCA APOE ADH1C CHMP2B FMR1 TRNS1 PRNP APP TUBA4A UCHL1 VPS13C GLUD2 ATXN2 TBK1 TRNF MAPT CSTB WFS1 ATP6 PPP2R2B PRNP XPR1 MAPT MAPT FTL NOS3 VCP DNM1L TYROBP SNCA C9ORF72 CSF1R PRNP TRNW SDHA CYTB WFS1 SNCB ZFYVE26 ARSA JPH3 PSEN2 CHMP2B APP SNCA TREM2 DGUOK EPM2A C9ORF72 ATXN2 APP PODXL MAPT LRRK2 ERCC8 HTRA2 DCTN1 TMEM106B HTRA1 GBA2 C19ORF12 HNRNPA2B1 SERPINI1 PLA2G6 CP CFAP43 PRNP CP APP HLA-DQB1 AARS2 VCP SNCA ND1 WDR45 MATR3 HTRA1 VPS35 MAPT MATR3 HTT C9ORF72 ATXN3 SNCA PANK2 TUBB4A GBA2 CHMP2B PRICKLE1 NR4A2 ATN1 ADA2 WDR45 LRRK2 PARK7 NHLRC1 TTR SQSTM1 ASAH1 VCP ERCC4 GIGYF2 APP ATP13A2 COX2 UBQLN2 HNRNPA1 DNAJC13 TRNK ATN1 VPS13A AMN CHMP2B HTT TOMM40 TYROBP SLC2A3 PRNP CLN3 SQSTM1 CST3 SDHAF1 PRNP ROGDI FBXO7 APP SDHB TRNV NPC2 ATP13A2 ABCD1 CHCHD10 SPG21 ATP6V1A GBA CERS1 PSEN1 PNPLA6 SPG21 APTX TREM2 TRNL1 RNF216 CLN6 ITM2B VPS13C GBA C9ORF72 GBA TBK1 PDGFB GBE1 MAPT DNAJC5 MAPT TRNE ATXN2 GBA TREM2 EPM2A TREM2 MMACHC NPC1 PLAU TYMP TRPM7 PPP2R2B TREX1 MPO HFE SNCA OPA1 NDP SQSTM1 PINK1 PSEN1 CFAP43 LRRK2 CTSF FTL DNAJC6 TRNQ SPAST RNF216 PSAP FMR1 ALDH18A1 COX1 TMEM106B ITM2B IRF6 TIMM8A ASAH1 TBP TARDBP RRM2B ATXN8OS PSEN1 SLC13A5 PINK1 PRNP ATP6 PDGFRB SCARB2 EIF4G1 SORL1 HNRNPA2B1 CUBN ATP6V0A2 MAPT VCP ROGDI PSEN1 PANK2 ATP13A2 PSEN1 NOTCH2NLC KCTD7 PRDM8 ND6 PSEN1 GRN NOTCH3 ABCA7 VCP ALDH18A1 ATP7B VCP DNMT1 GRN NHLRC1 ATP13A2 CHCHD10 A2M PRKAR1B TBP CHMP2B ATP6V1E1 RAB39B CYP27A1 TRNC DCTN1 SDHD TARDBP Protein Mutations 1
V158M SNP 0
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 monthsSecondary 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 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 months