- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03602391
The Senior Companion Program Plus (SCP Plus)
The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers
Alzheimer's disease and related dementia (ADRD) is one of the most challenging chronic health conditions in the United States and considerable disparities exist in the diagnosis and prevalence of ADRD among communities of color. Research suggests that ADRD caregiver interventions have demonstrated efficacy, however, it remains unknown whether existing ADRD caregiver interventions are useful or accessible to African American ADRD caregivers in community settings.
The primary goal of the proposed project is to develop an in-home psychoeducational intervention (The Senior Companion Program Plus, or SCP Plus) that is accessible, sustainable, and affordable for African American ADRD caregivers. The SCP Plus will focus on African American ADRD caregivers who are particularly affected by poverty, discrimination, and barriers to health care services and supports. A recent pilot study has established the feasibility and utility of SCP Plus. With the assistance of 6 student research assistants over the course of the project, we will implement the SCP Plus at sites in Texas, Louisiana, and Arkansas, recruiting approximately 114 participants. The participants will be randomized with 57 caregivers receiving the SCP Plus and 57 caregivers receiving services as usual with the Senior Companion Program. A weekly, 60 minute psychoeducational module will be delivered face-to-face across 9 weeks and will focus on education about ADRD, behavior management, communication skills, and aspects of providing care that enhance meaning such as spirituality. In order to provide an accessible and cost effective intervention that is potentially sustainable, senior companions will be trained to provide the intervention in the homes of the African American ADRD caregivers.
Specific Aim 1. Determine whether SCP Plus reduces level of burden and stress among African American caregivers over a 3- and 6-month period when compared to a usual care control group.
Specific Aim 2. Ascertain if SCP Plus improves coping skills among African American caregivers over a 3- and 6-month period when compared to a usual care control group.
Specific Aim 3. Examine whether SCP Plus improves the level of satisfaction with support social among African American caregivers over a 3- and 6- month period when compared to a usual care control group.
Specific Aim 4. Explore and interpret the statistical results obtained in the first quantitative phase to help explain why participants who scored in the lower and upper quartiles on caregiver burden/stress were impacted or not by the usefulness of the intervention.
Successful design, delivery, and evaluation of the SCP Plus will lead to a cost effective, sustainable, and accessible intervention that can be implemented in other Senior Companion programs across the country, thus maximizing its impact as a community-based program to address the needs of African American ADRD caregivers.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
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Dallas, Texas, United States, 75219
- The Senior Source
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
A. Senior Companions have to be currently participating in the Senior Companions Program B. Senior Companions have to be currently providing respite services to the caregivers C. Family caregivers must self-identify as African American D. Family caregivers must be at least 21 years of age E. Family caregivers must provide unpaid care for an older adult with ADRD F. The persons with ADRD must have a physician diagnosis of ADRD and live at home in the community.
G. The capacity for and willingness to provide written informed consent, to accept the randomized group assignment, to attend all study related visits, and to comply with the study protocol.
Exclusion Criteria:
A. Family caregivers who are involved in another caregiver psychosocial intervention study or have an acute illness that would prevent them from participating for at least 6 months will not be eligible.
B. Self-identified non-African American caregivers will be excluded from enrollment in the study, because of the specificity of the cultural components of the Senior Companion Program Plus being tested.
C. Senior Companions who are not serving a client with ADRD from African American backgrounds will be excluded as the Senior Companion Program Plus is designed for dementia family caregivers.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: SCP Plus
|
The primary goal of the proposed project is to develop an in-home psychoeducational intervention (Senior Companion Program Plus, or SCP Plus) that is accessible, affordable, and sustainable for low-income African American ADRD caregivers.
A weekly, 60 minute psychoeducational module will be delivered face-to-face across 9 weeks and will focus on education about ADRD, behavior management, communication skills, and aspects of providing care that enhance meaning such as spirituality.
In order to provide an accessible intervention that is potentially sustainable, Senior Companions will be trained to provide the intervention in the homes of the African American ADRD caregivers.
|
|
No Intervention: Services as usual
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Caregiver Burden and Stress
Time Frame: pre, post, 6-month follow up
|
The 22-item version of the Zarit Burden Interview (ZBI) will be used to test caregiver stress and/or burden.
The ZBI was developed to measure burden among caregivers of community-dwelling persons with dementia.
The items are scored from 0 (never); 1 (rarely); 2 (sometimes); 3 (quite frequently); 4 (nearly always) with higher scores indicating higher levels of distress.
Total scores can range from 0 to 88. Median of the 22 items is analyzed.
Overall median of participants is reported.
All survey data collection involved a researcher asking the ADRD caregiver the survey questions over the telephone and documenting their responses.
|
pre, post, 6-month follow up
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|
Change in Caregiver Coping Skills
Time Frame: pre, post, 6-month follow up
|
The Brief Cope Scale will be used to measure coping skills.
The Brief Cope questionnaire consists of 28 items measuring the ways/strategies caregivers have been coping with the stress in their life with 4-point scale ranging from "I have not been doing this at all"(1) to "I have been doing this a lot" (4).
This Brief Cope scale consists of 14 subscales (with 2 items for each subscale).
Sum scores for each subscale will be calculated, ranging from 2 to 8, with higher scores indicating better coping skills.
A final total sum score will also be calculated by combining all the sum scores of the 14 subscales, ranged from 28 to 112.
The higher the total scores, the better the coping skills.
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pre, post, 6-month follow up
|
|
Change in Caregiver Level of Satisfaction With Social Support
Time Frame: pre, post, 6-month follow up
|
Levels of satisfaction with social support was measured by asking caregivers 4 questions about how they feel satisfied with the support they received in the past month from friends, family, and others regarding: (1) overall help from friends and family, (2) help with transportation, housework and yard work, and shopping from friends and family; (3) help with support, comfort, interest and concern from others, (4) suggestions, clarifications, and sharing of similar experiences from others.
Each item was measured with 3 Likert scale ranged from (0) 'Not at all', (1) 'a little', (2) 'moderately', to (3) 'very'.
The sum score ranged from 0-12 with higher scores indicating higher level of satisfaction with social support.
Overall median of participants is reported.
All survey data collection involved a researcher asking the ADRD caregiver the survey questions over the telephone and documenting their responses.
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pre, post, 6-month follow up
|
Collaborators and Investigators
Collaborators
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
- 2017-0431
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
product manufactured in and exported from the U.S.
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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