- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667924
Utilizing Senior Companions to Enhance Dementia Care
Utilizing Senior Companions to Enhance Dementia Care Services and Supports
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- School of Public Health
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PorchLight Project Intervention Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Utilization of LTSS by PWML and Caregivers
Time Frame: Baseline, 1-month, 3-month
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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).
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Baseline, 1-month, 3-month
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Quality of Primary Care Interactions
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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Caregiver Distress: Burden
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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Caregiver Distress: Depressive Symptoms
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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PWML Well-being
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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PWML Depression
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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PWML Quality of Life
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Self-efficacy
Time Frame: Baseline, 1-month, 3-month
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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.
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Baseline, 1-month, 3-month
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004176
- R61AG061903 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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