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The Senior Companion Program Plus (SCP Plus)

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ClinicalTrials.gov Identifier: NCT03602391
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : May 17, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Noelle Fields, The University of Texas at Arlington

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Family Alzheimer Dementia Behavioral: SCP Plus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers
Actual Study Start Date : May 16, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : June 30, 2021


Arm Intervention/treatment
Experimental: SCP Plus Behavioral: 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



Primary Outcome Measures :
  1. Change in caregiver burden and stress [ Time Frame: pre, post, 6-month follow up ]
    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.

  2. 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.

  3. Change in caregiver level of satisfaction with social support [ Time Frame: pre, post, 6-month follow up ]
    The measure of social support will encompass 13 items from four domains: received support, satisfaction with support, social support network, and negative interactions.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

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): NCT03602391


Contacts
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Contact: Noelle L Fields, PhD 6149479783 noellefields@uta.edu

Locations
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United States, Texas
The Senior Source Recruiting
Dallas, Texas, United States, 75219
Contact: Noelle Fields         
Sponsors and Collaborators
The University of Texas at Arlington
National Institute on Aging (NIA)

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Responsible Party: Noelle Fields, Assistant Professor, The University of Texas at Arlington
ClinicalTrials.gov Identifier: NCT03602391     History of Changes
Other Study ID Numbers: 2017-0431
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dementia
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases