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Utilizing Senior Companions to Enhance Dementia Care

Primary Purpose

Alzheimer Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PorchLight Project
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Caregiving, Community-based care, Long-term services and supports, Volunteer

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criterion for the Senior Companion: 1) be a current volunteer through LSS-MN 2) be willing to complete the CARES® 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.

Sites / Locations

  • School of Public Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PorchLight Project Intervention Group

Arm Description

Participants in the intervention group will receive home-based support and respite services from PorchLight Project trained Senior Companion volunteers of the Lutheran Social Services of Minnesota.

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 10, 2018
Last Updated
November 3, 2022
Sponsor
University of Minnesota
Collaborators
Johns Hopkins University, Brown University, National Institute on Aging (NIA), University of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT03667924
Brief Title
Utilizing Senior Companions to Enhance Dementia Care
Official Title
Utilizing Senior Companions to Enhance Dementia Care Services and Supports
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Johns Hopkins University, Brown University, National Institute on Aging (NIA), University of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Caregiving, Community-based care, Long-term services and supports, Volunteer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Enrollment: Number of participants: 44 (33 senior volunteers; 7 clients (PWML); 4 caregivers)
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PorchLight Project Intervention Group
Arm Type
Experimental
Arm Description
Participants in the intervention group will receive home-based support and respite services from PorchLight Project trained Senior Companion volunteers of the Lutheran Social Services of Minnesota.
Intervention Type
Behavioral
Intervention Name(s)
PorchLight Project
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utilization of LTSS by PWML and Caregivers
Description
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).
Time Frame
Baseline, 1-month, 3-month
Title
Quality of Primary Care Interactions
Description
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.
Time Frame
Baseline, 1-month, 3-month
Title
Caregiver Distress: Burden
Description
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.
Time Frame
Baseline, 1-month, 3-month
Title
Caregiver Distress: Depressive Symptoms
Description
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.
Time Frame
Baseline, 1-month, 3-month
Title
PWML Well-being
Description
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.
Time Frame
Baseline, 1-month, 3-month
Title
PWML Depression
Description
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.
Time Frame
Baseline, 1-month, 3-month
Title
PWML Quality of Life
Description
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.
Time Frame
Baseline, 1-month, 3-month
Secondary Outcome Measure Information:
Title
Caregiver Self-efficacy
Description
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.
Time Frame
Baseline, 1-month, 3-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criterion for the Senior Companion: 1) be a current volunteer through LSS-MN 2) be willing to complete the CARES® 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.
Facility Information:
Facility Name
School of Public Health
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34036120
Citation
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;7:23337214211017651. doi: 10.1177/23337214211017651. eCollection 2021 Jan-Dec.
Results Reference
result

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Utilizing Senior Companions to Enhance Dementia Care

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