Alzheimer Disease Clinical Trial
Official title:
Utilizing Senior Companions to Enhance Dementia Care Services and Supports
Verified date | November 2022 |
Source | University of Minnesota |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The inability of healthcare systems to effectively manage Alzheimer's disease and related dementias (ADRD) often results in families remaining unaware of important community-based, long-term services and supports (LTSS) that could help to mitigate the negative effects of cognitive impairment. This project will feature a collaboration between Lutheran Social Service of Minnesota and the University of Minnesota to evaluate a novel adaption of the volunteer Senior Companion Program (SCP) to: a) assist families better manage ADRD at home; b) identify and facilitate the use of LTSS; and c) improve engagement with primary care providers throughout the state of Minnesota. If successful, the PorchLight Project will offer a potentially efficient, wide-ranging service model for states and communities to implement for persons with ADRD and their caregiving families.
Status | Completed |
Enrollment | 44 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion criterion for the Senior Companion: 1) be a current volunteer through LSS-MN 2) be willing to complete the CARESĀ® modules and 4-part training session provided by UMN research staff and 3) be 21 years of age or older. Inclusion criteria for the PWML will be based on one of the following scenarios: 1) the person or their caregiver are concerned about the person's memory loss, 2) the person has a physician diagnosis of ADRD, 3) the caregiver (or PWML) scores 2 or greater on the AD8. The PWML must be 55 years of age or older. Inclusion criteria for the caregiver is that the individual is 1) 21 years of age or older, 2) self-identifies as someone who provides help to the PWML because of their cognitive impairments, and 3) the care recipient is eligible for the study as per the above criteria. Exclusion Criteria: A PWML or caregiver will be ineligible if they have a diagnosis of a serious psychiatric illness, their symptoms have worsened in the last 6 months, and they don't receive steady, ongoing treatment for those symptoms. |
Country | Name | City | State |
---|---|---|---|
United States | School of Public Health | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota | Brown University, Johns Hopkins University, National Institute on Aging (NIA), University of Texas |
United States,
Rosebush CE, Stabler H, Nkimbeng M, Louwagie K, Fields NL, Jutkowitz E, Shippee TP, Gaugler JE. The Porchlight Project: A Pilot Study to Adapt the Senior Companion Program to Enhance Memory Care Services and Supports. Gerontol Geriatr Med. 2021 May 14;7:2 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Utilization of LTSS by PWML and Caregivers | Community-based service utilization of PWML and caregivers will be assessed by asking participants to identify (from a fixed list of options) fifteen different home and community-based services (HCBS). | Baseline, 1-month, 3-month | |
Primary | Quality of Primary Care Interactions | A 3-item measure of quality of interaction during primary care provider encounters. The total mean of item-responses was calculated, with a minimum value of 1 and a maximum value of 4. The higher scores mean higher quality interactions. | Baseline, 1-month, 3-month | |
Primary | Caregiver Distress: Burden | Caregiver distress will be ascertained with the 22-item Zarit Burden Interview. Scores were summed; the higher the score, the more burden perceived. Minimum score of 0, high score of 88. | Baseline, 1-month, 3-month | |
Primary | Caregiver Distress: Depressive Symptoms | Caregiver distress will be ascertained with the 20-item Center for Epidemiological Studies-Depression scale. An average/mean, total score of item-responses was computed, with a minimum score of 1 and a high score of 4. The higher the score, the more depressive symptoms experienced. | Baseline, 1-month, 3-month | |
Primary | PWML Well-being | We will assess the PWML health related quality of life using the EQ-5D-5L Visual Analog Scale. The measure is single score of a minimum of 0 and maximum of 100. Higher scores indicate better health. | Baseline, 1-month, 3-month | |
Primary | PWML Depression | PWML Depression will be ascertained using the 15-item Geriatric Depression Scale Short Form. The scale score is summed, with a minimum score of 0 and a maximum of 15. The higher the score, the greater the depressive symptoms experienced/indicated. | Baseline, 1-month, 3-month | |
Primary | PWML Quality of Life | PWML Quality of Life will be ascertained using the 13-item Quality of Life Alzheimer's Disease-Measure (QOL-AD). The measure score is summed. The minimum score is 13 and the maximum score is 52. The higher the score, the greater perceived quality of life. | Baseline, 1-month, 3-month | |
Secondary | Caregiver Self-efficacy | An 8-item measure of caregiver self-efficacy developed by Fortinsky et al. (2002). The score is summed; the higher the score, the more self-efficacy the caregiver perceives. The minimum score on the scale is 8, the maximum is 40. | Baseline, 1-month, 3-month |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04044495 -
Sleep, Rhythms and Risk of Alzheimer's Disease
|
N/A | |
Completed |
NCT04079803 -
PTI-125 for Mild-to-moderate Alzheimer's Disease Patients
|
Phase 2 | |
Terminated |
NCT03052712 -
Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies
|
N/A | |
Recruiting |
NCT04520698 -
Utilizing Palliative Leaders In Facilities to Transform Care for Alzheimer's Disease
|
N/A | |
Active, not recruiting |
NCT04606420 -
Can Lifestyle Changes Reverse Early-Stage Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05820919 -
Enhancing Sleep Quality for Nursing Home Residents With Dementia - R33 Phase
|
N/A | |
Terminated |
NCT03672474 -
REGEnLIFE RGn530 - Feasibility Pilot
|
N/A | |
Completed |
NCT03430648 -
Is Tau Protein Linked to Mobility Function?
|
||
Recruiting |
NCT04522739 -
Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease
|
Phase 4 | |
Recruiting |
NCT05557409 -
A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Alzheimer's Disease Agitation
|
Phase 3 | |
Recruiting |
NCT04949750 -
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
|
N/A | |
Recruiting |
NCT05288842 -
Tanycytes in Alzheimer's Disease and Frontotemporal Dementia
|
||
Completed |
NCT06194552 -
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
|
Phase 1 | |
Completed |
NCT03239561 -
Evaluation of Tau Protein in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
|
Early Phase 1 | |
Completed |
NCT03184467 -
Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Alzheimer Patients
|
Phase 2 | |
Active, not recruiting |
NCT03676881 -
Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
|
||
Terminated |
NCT03487380 -
Taxonomic and Functional Composition of the Intestinal Microbiome: a Predictor of Rapid Cognitive Decline in Patients With Alzheimer's Disease
|
N/A | |
Completed |
NCT05538455 -
Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases
|
N/A | |
Recruiting |
NCT05328115 -
A Study on the Safety, Tolerability and Immunogenicity of ALZ-101 in Participants With Early Alzheimer's Disease
|
Phase 1 | |
Completed |
NCT05562583 -
SAGE-LEAF: Reducing Burden in Alzheimer's Disease Caregivers Through Positive Emotion Regulation and Virtual Support
|
N/A |