Utilizing Senior Companions to Enhance Dementia Care
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|ClinicalTrials.gov Identifier: NCT03667924|
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease Dementia||Behavioral: Senior-Companion Dementia Group||Phase 2|
This R61 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 SCP-Dementia (SCP-D) has the following aims):
1. Implement SCP-D for 25 persons with ADRD or memory concerns 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 SCP-D 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 SCP-D 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 SCP-D 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, the investigators will finalize and refine effective training approaches for SCP-D Companions (SC-D), identify and confirm stakeholder-centric measures, and enhance the overall implementation of the SCP-D to inform a subsequent R33 Phase.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Utilizing Senior Companions to Enhance Dementia Care Services and Supports|
|Estimated Study Start Date :||October 2018|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Senior Companion-Dementia Group
Participants in the Senior Companion-Dementia group will receive home-based support and respite services from Senior Companion-Dementia trained volunteers of the Lutheran Social Services of Minnesota.
Behavioral: Senior-Companion Dementia Group
Senior Companions who deliver the Senior Companion-Dementia (SCP-D) (i.e., SC-Ds) will complete the online CARES® Dementia Care Specialist training modules, ongoing monthly case review and discussions as overseen by the University of Minnesota (UMN) research team (the Principal Investigator/PI, research coordinator) and Lutheran Social Services of Minnesota, and receive an adapted lay person training module. Senior Companions who deliver the SCP-D will also be trained to identify community-based LTSS. The adapted SC-D training via monthly web/teleconference sessions will occur in Months 5-7. Following training, the monthly web/teleconference sessions will largely focus on review of specific cases, discussion of challenges and potential solutions, provision of additional education as needed, and ensuring that SC-Ds are regularly engaged with persons with ADRD and family members throughout SCP-D delivery.
- Change in the frequency of service utilization for person with ADRD [ Time Frame: Baseline, 1-month, 3-month ]Community-based service utilization of persons with ADRD will be assessed by asking family caregivers to identify (from a fixed list of options) fifteen different home and community-based services (HCBS). This is a "yes/no" checklist and is summed to create a total score: the higher the score, the more services used.
- Change in perceived quality of primary care provider interactions [ Time Frame: Baseline, 1-month, 3-month ]A 19-item "yes/no" measure of quality of interaction during encounters with primary care providers will be administered to respondents. A total score is created by summing the item responses, with greater scores equaling greater perceived quality in primary care provider interactions.
- Change in perceived caregiver burden [ Time Frame: Baseline, 1-month, 3-month ]The 22-item Zarit Burden Interview self-report survey measure. Item responses range from 0 "never" to 4 "nearly always." Scores are summed and can range from a score of 0 (no burden) to 88 (high burden).
- Change in frequency and perceived intensity of respondent depressive symptoms [ Time Frame: Baseline, 1-month, 3-month ]The 20-item Center for Epidemiological Studies Depression (CES-D) survey measure is used to assess respondents' depressive symptoms. Item responses range from 1 = "Rarely or none of the time (less than 1 day)" to 5 = "Most of the time (5-7 days)." The total CES-D score is summed, with a range of 20 (little to no depressive symptoms) to 100 (frequent depressive symptoms).
- Change in person's wtih ADRD perceived well-being [ Time Frame: Baseline, 1-month, 3-month ]We will assess the person with ADRDs health related quality of life using the EQ-5D-5L and the Health Utilities Index 2/3 (HUI). For both the EQ-5D-5L and HUI caregivers will serve as proxies and these measures will be used to generate the person with ADRDs health utility that will inform the cost-effectiveness analysis. Total scores are sums of the various item-responses; the higher the score, the greater the well-being.
- Change in perceived caregiver self-efficacy [ Time Frame: Baseline, 1-month, 3-month ]An 8-item survey measure of caregiver self-efficacy. Item responses range from 1 "very unconfident" to 5 "very confident." Scores are summed and can range from a score of 1 (low self-efficacy) to 40 (high self-efficacy).
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
|Contact: Joseph E. Gaugler, PhDfirstname.lastname@example.org|
|Contact: Amanda Weinstein, MSemail@example.com|