Utilizing Senior Companions to Enhance Dementia Care
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03667924 |
|
Recruitment Status :
Completed
First Posted : September 12, 2018
Results First Posted : November 25, 2022
Last Update Posted : November 25, 2022
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease Dementia | Behavioral: PorchLight Project | Not Applicable |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 44 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Intervention Model Description: | Enrollment: Number of participants: 44 (33 senior volunteers; 7 clients (PWML); 4 caregivers) |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Utilizing Senior Companions to Enhance Dementia Care Services and Supports |
| Actual Study Start Date : | April 29, 2019 |
| Actual Primary Completion Date : | August 31, 2020 |
| Actual Study Completion Date : | August 31, 2020 |
| 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.
|
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. |
- Utilization of LTSS by PWML and Caregivers [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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 [ Time Frame: Baseline, 1-month, 3-month ]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.
- Caregiver Self-efficacy [ Time Frame: Baseline, 1-month, 3-month ]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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03667924
| United States, Minnesota | |
| School of Public Health | |
| Minneapolis, Minnesota, United States, 55455 | |
Documents provided by University of Minnesota:
| Responsible Party: | University of Minnesota |
| ClinicalTrials.gov Identifier: | NCT03667924 |
| Other Study ID Numbers: |
STUDY00004176 R61AG061903 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 12, 2018 Key Record Dates |
| Results First Posted: | November 25, 2022 |
| Last Update Posted: | November 25, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
|
Caregiving Community-based care Long-term services and supports Volunteer |
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |