Trial Outcomes & Findings for The Senior Companion Program Plus (NCT NCT03602391)

Last Updated: 2024-10-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

pre, post, 6-month follow up

Results posted on

2024-10-01

Participant Flow

The original participant enrollment goal was 114 participants. However, due to COVID-19, only 20 participants consented and were enrolled in the study.

Participant milestones

Participant milestones
Measure	SCP Plus Intervention 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 to African American ADRD caregivers 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, who are volunteers as part of the AmeriCorps Seniors Program, will be trained to provide the intervention in the homes of the African American ADRD caregivers. The care recipients (CR) with ADRD are not included as participants in the study.	Services as Usual This group receives services as usual from the Senior Companion Program. Services as usual means that the Senior Companion provides respite to the family caregiver. The care recipient (CR) with ADRD is not included as a participant in the study.
Overall Study STARTED	11	9
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	SCP Plus Intervention 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 to African American ADRD caregivers 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, who are volunteers as part of the AmeriCorps Seniors Program, will be trained to provide the intervention in the homes of the African American ADRD caregivers. The care recipients (CR) with ADRD are not included as participants in the study.	Services as Usual This group receives services as usual from the Senior Companion Program. Services as usual means that the Senior Companion provides respite to the family caregiver. The care recipient (CR) with ADRD is not included as a participant in the study.
Overall Study COVID-19	7	6

Baseline Characteristics

The Senior Companion Program Plus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SCP Plus n=11 Participants 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.	Services as Usual n=9 Participants Participants will receive services as usual from the Senior Companion Program.	Total n=20 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	58 years n=7 Participants	60.5 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	11 Participants n=5 Participants	9 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	9 participants n=7 Participants	20 participants n=5 Participants
Self-rated health	3 units on a scale n=5 Participants	3 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Financial strain	3 units on a scale n=5 Participants	2 units on a scale n=7 Participants	3 units on a scale n=5 Participants
Marital status Married	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Marital status Divorced	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Marital status Widowed/Other	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Living arrangement	2 people living in household n=5 Participants	2 people living in household n=7 Participants	2 people living in household n=5 Participants
Education High school graduate or below	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Education Some college	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Education College graduation or above	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Employment Full employment	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Employment Part-time employment	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Employment Retired/Unemployed	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Religiosity	3 units on a scale n=5 Participants	4 units on a scale n=7 Participants	3.5 units on a scale n=5 Participants
Relationship to the care recipient Spouse	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Relationship to the care recipient Adult child	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Relationship to the care recipient Sibling/other	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Length of care	5 years n=5 Participants	5 years n=7 Participants	5 years n=5 Participants
Use of formal services Once or less than once a week	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Use of formal services Several times a week	10 Participants n=5 Participants	6 Participants n=7 Participants	16 Participants n=5 Participants
Use of formal services Every day	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Satisfaction with formal services Unsatisfied	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Satisfaction with formal services Satisfied	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Satisfaction with formal services Strongly satisfied	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Daily care hours	12 hours per day n=5 Participants	12 hours per day n=7 Participants	12 hours per day n=5 Participants

PRIMARY outcome

Timeframe: pre, post, 6-month follow up

Population: 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.

Outcome measures

Outcome measures
Measure	SCP Plus Intervention n=4 Participants 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.	Services as Usual n=3 Participants This group receives services as usual from the Senior Companion Program.
Change in Caregiver Burden and Stress Pre-test	40 score on a scale Interval 16.0 to 63.0	18 score on a scale Interval 8.0 to 44.0
Change in Caregiver Burden and Stress Post-test	32 score on a scale Interval 10.0 to 45.0	18.5 score on a scale Interval 12.0 to 39.0
Change in Caregiver Burden and Stress 6-month follow up	15 score on a scale Interval 13.0 to 30.0	7 score on a scale Interval 4.0 to 10.0

PRIMARY outcome

Timeframe: pre, post, 6-month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SCP Plus Intervention n=4 Participants 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.	Services as Usual n=3 Participants This group receives services as usual from the Senior Companion Program.
Change in Caregiver Coping Skills Pre-test	81 score on a scale Interval 55.0 to 93.0	73 score on a scale Interval 67.0 to 98.0
Change in Caregiver Coping Skills Post-test	96 score on a scale Interval 74.0 to 101.0	82 score on a scale Interval 74.0 to 98.0
Change in Caregiver Coping Skills 6-month Follow up	79 score on a scale Interval 72.0 to 94.0	90 score on a scale Interval 61.0 to 101.0

PRIMARY outcome

Timeframe: pre, post, 6-month follow up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	SCP Plus Intervention n=4 Participants 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.	Services as Usual n=3 Participants This group receives services as usual from the Senior Companion Program.
Change in Caregiver Level of Satisfaction With Social Support Pre-test	3.5 score on a scale Interval 0.0 to 6.0	9 score on a scale Interval 5.0 to 12.0
Change in Caregiver Level of Satisfaction With Social Support Post-test	4 score on a scale Interval 3.0 to 12.0	12 score on a scale Interval 9.0 to 12.0
Change in Caregiver Level of Satisfaction With Social Support 6-month follow up	11.5 score on a scale Interval 5.0 to 12.0	12 score on a scale Interval 9.0 to 12.0

Adverse Events

SCP Plus Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Services as Usual

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

JEREMY A FORSBERG

University of Texas at Arlington

Phone: 8172722105

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place