FamilySCP PlusNCT03602391

The Senior Companion Program Plus

A study testing SCP Plus in people with Family and Alzheimer Dementia, run by The University of Texas at Arlington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Family, Alzheimer Dementia
What is being tested?: SCP Plus
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 16 May 2019to 30 Jun 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.
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.

Who cannot join

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.
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.
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.

Trial locations and contacts

1 site in 1 country.

United States1 site

The Senior Source
Dallas, Texas, 75219

Other trials in United States

About this study

Official title: 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.

Conditions: Family, Alzheimer Dementia
Being tested: SCP Plus
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SCP PlusBehavioural
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.

Study groups in NCT03602391
Study group	Role	What they receive
SCP Plus	Experimental	Not described Receives: Behavioral: SCP Plus
Services as usual	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Caregiver Burden and Stress
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.
Measured: pre, post, 6-month follow up
Change in Caregiver Coping Skills
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.
Measured: pre, post, 6-month follow up
Change in Caregiver Level of Satisfaction With Social Support
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.
Measured: pre, post, 6-month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 May 201930 Jun 2023

First posted26 Jul 2018
Study start16 May 2019
Primary completion31 Mar 2023
Study completion30 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for FamilyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03602391
Sponsor's protocol ID: 2017-0431
Acronym: SCP Plus
Status last verified: Sep 2024
First submitted: 6 Jul 2018
Last updated: 1 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fields NL, Xu L, Williams IC, Gaugler JE, Cipher DJ. The Senior Companion Program Plus for African American Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 24;12:e49679. doi: 10.2196/49679.
PubMed 37486759

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Senior Companion Program Plus (SCP Plus): A Psychoeducational Intervention for African American Dementia Caregivers
ClinicalTrials.gov ID: NCT03602391
Acronym / sponsor ID: SCP Plus / 2017-0431
Conditions: Family, Alzheimer Dementia
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: The University of Texas at ArlingtonUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: 16 May 2019 (actual)
Primary completion: 31 Mar 2023 (actual)
Study completion: 30 Jun 2023 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 5 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
SCP Plus	Experimental	Behavioral: SCP Plus
Services as usual	No intervention	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.
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.

Key exclusion criteria (3 listed)

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.
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.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SCP PlusThe 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.	Behavioural	SCP Plus

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 5 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SCP Plus Intervention	11	4
Services as Usual	9	3

Primary outcome: Change in Caregiver Burden and Stress

Time frame: pre, post, 6-month follow up. Median (Full Range). Unit: score on a scale

Measure	SCP Plus Intervention n = 4	Services as Usual n = 3
Pre-test	40 (16 to 63)	18 (8 to 44)
Post-test	32 (10 to 45)	18.5 (12 to 39)
6-month follow up	15 (13 to 30)	7 (4 to 10)

Population analysed: Analysis population is the same as those who were enrolled, completed a baseline survey, completed the intervention, and remained in the study for the 6 month follow-up.

Primary outcome: Change in Caregiver Coping Skills

Time frame: pre, post, 6-month follow up. Median (Full Range). Unit: score on a scale

Measure	SCP Plus Intervention n = 4	Services as Usual n = 3
Pre-test	81 (55 to 93)	73 (67 to 98)
Post-test	96 (74 to 101)	82 (74 to 98)
6-month Follow up	79 (72 to 94)	90 (61 to 101)

Population analysed: Analysis population is the same as those who were enrolled, completed a baseline survey, completed the intervention, and remained in the study for the 6 month follow-up.

Primary outcome: Change in Caregiver Level of Satisfaction With Social Support

Time frame: pre, post, 6-month follow up. Median (Full Range). Unit: score on a scale

Measure	SCP Plus Intervention n = 4	Services as Usual n = 3
Pre-test	3.5 (0 to 6)	9 (5 to 12)
Post-test	4 (3 to 12)	12 (9 to 12)
6-month follow up	11.5 (5 to 12)	12 (9 to 12)

Population analysed: Analysis population is the same as those who were enrolled, completed a baseline survey, completed the intervention, and remained in the study for the 6 month follow-up.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SCP Plus Intervention	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Services as Usual	0 of 9 (0%)	0 of 9 (0%)	0 of 9

Limitations and caveats (from the sponsor): The results of this study must be interpreted with caution, as there are several limitations that provide lessons for future studies. The final sample size was very small, due in part to the negative impact of COVID-19. Due to the challenges and risks of conducting an in-person intervention during COVID-19, data collection was suspended in March 2020. Therefore, we could not control for any confounding variables when examining the preliminary effectiveness of the SCP Plus program.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37486759Fields NL, Xu L, Williams IC, Gaugler JE, Cipher DJ. The Senior Companion Program Plus for African American Caregivers of Persons With Alzheimer Disease and Related Dementias: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jul 24;12:e49679. doi: 10.2196/49679.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SCP Plus in people with Family and Alzheimer Dementia, run by The University of Texas at Arlington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Caregiver Burden and Stress (time frame: pre, post, 6-month follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03602391, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.