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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03667924
Other study ID # STUDY00004176
Secondary ID R61AG061903
Status Completed
Phase N/A
First received
Last updated
Start date April 29, 2019
Est. completion date August 31, 2020

Study information

Verified date November 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This project will evaluate a novel adaption of the Senior Companion Program (SCP) administered by Lutheran Social Service of Minnesota to assist families better manage their relatives' Alzheimer's disease or related dementias (ADRDs); identify and facilitate use of community-based long-term services and supports (LTSS); and improve engagement with healthcare providers. This intervention, called the PorchLight Project has the following aims: Specific Aim 1. Implement PorchLight Project for 25 persons with ADRD or memory concerns (collectively, persons with memory loss [PWML]) and/or their caregivers in one urban and rural region of Minnesota. A convergent parallel mixed methods design [(QUAN+QUAL)-->QUAL] will be utilized to examine the feasibility, acceptability, and utility of PorchLight Project for 25 families and their SC-Ds (n = 20) over a 3-month period (i.e., Stage I of the NIH Stage Model). Specific Aim 2. Refine PorchLight Project delivery and implementation for efficacy evaluation. Activities to support this aim will include assessment of R61 milestones and incorporation of R61 findings to refine the PorchLight Project prior to efficacy evaluation. Through stakeholder engagement with the Dementia Healthcare Research Advisory Group (DHR) as well as analysis of the various quantitative and qualitative data elements collected during this Phase, we will finalize and refine effective training approaches for PorchLight Project Senior Companions (SCs), identify and confirm stakeholder-centric measures, and enhance the overall implementation of the PorchLight Project to inform a subsequent R33 Phase.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
PorchLight Project
Senior Companions (or other LSS-MN volunteers providing senior companionship services) who deliver the PorchLight Project will complete online CARES® Dementia Care Specialist training modules, additional trainings delivered by the research team (1. overview of the PorchLight Project, 2. review of the National Consensus Guidelines on Palliative Care, 3. review of the list of guided questions, and 4. review of journaling approach and LTSS resources), and participate in unstructured monthly check-ins (discussions and case review as applicable) with the research team.

Locations

Country Name City State
United States School of Public Health Minneapolis Minnesota

Sponsors (5)

Lead Sponsor Collaborator
University of Minnesota Brown University, Johns Hopkins University, National Institute on Aging (NIA), University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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
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