Alzheimer Dementia, Family
Conditions
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.
Interventions
BEHAVIORALSCP 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.
Sponsors
National Institute on Aging (NIA)
The University of Texas at Arlington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Caregiver Burden and Stress | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
The original participant enrollment goal was 114 participants. However, due to COVID-19, only 20 participants consented and were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| SCP Plus 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. | 11 |
| Services as Usual Participants will receive services as usual from the Senior Companion Program. | 9 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | COVID-19 | 7 | 6 |
Baseline characteristics
| Characteristic | Services as Usual | Total | SCP Plus |
|---|---|---|---|
| Age, Continuous | 58 years | 60.5 years | 62 years |
| Daily care hours | 12 hours per day | 12 hours per day | 12 hours per day |
| Education College graduation or above | 1 Participants | 2 Participants | 1 Participants |
| Education High school graduate or below | 2 Participants | 8 Participants | 6 Participants |
| Education Some college | 6 Participants | 10 Participants | 4 Participants |
| Employment Full employment | 6 Participants | 9 Participants | 3 Participants |
| Employment Part-time employment | 1 Participants | 5 Participants | 4 Participants |
| Employment Retired/Unemployed | 2 Participants | 6 Participants | 4 Participants |
| Financial strain | 2 units on a scale | 3 units on a scale | 3 units on a scale |
| Length of care | 5 years | 5 years | 5 years |
| Living arrangement | 2 people living in household | 2 people living in household | 2 people living in household |
| Marital status Divorced | 1 Participants | 5 Participants | 4 Participants |
| Marital status Married | 6 Participants | 11 Participants | 5 Participants |
| Marital status Widowed/Other | 2 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 9 participants | 20 participants | 11 participants |
| Relationship to the care recipient Adult child | 7 Participants | 13 Participants | 6 Participants |
| Relationship to the care recipient Sibling/other | 2 Participants | 6 Participants | 4 Participants |
| Relationship to the care recipient Spouse | 0 Participants | 1 Participants | 1 Participants |
| Religiosity | 4 units on a scale | 3.5 units on a scale | 3 units on a scale |
| Satisfaction with formal services Satisfied | 4 Participants | 12 Participants | 8 Participants |
| Satisfaction with formal services Strongly satisfied | 4 Participants | 6 Participants | 2 Participants |
| Satisfaction with formal services Unsatisfied | 1 Participants | 2 Participants | 1 Participants |
| Self-rated health | 3 units on a scale | 3 units on a scale | 3 units on a scale |
| Sex: Female, Male Female | 9 Participants | 17 Participants | 8 Participants |
| Sex: Female, Male Male | 0 Participants | 3 Participants | 3 Participants |
| Use of formal services Every day | 2 Participants | 3 Participants | 1 Participants |
| Use of formal services Once or less than once a week | 1 Participants | 1 Participants | 0 Participants |
| Use of formal services Several times a week | 6 Participants | 16 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SCP Plus Intervention | Change in Caregiver Burden and Stress | Pre-test | 40 score on a scale |
| SCP Plus Intervention | Change in Caregiver Burden and Stress | Post-test | 32 score on a scale |
| SCP Plus Intervention | Change in Caregiver Burden and Stress | 6-month follow up | 15 score on a scale |
| Services as Usual | Change in Caregiver Burden and Stress | Pre-test | 18 score on a scale |
| Services as Usual | Change in Caregiver Burden and Stress | Post-test | 18.5 score on a scale |
| Services as Usual | Change in Caregiver Burden and Stress | 6-month follow up | 7 score on a scale |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SCP Plus Intervention | Change in Caregiver Coping Skills | Pre-test | 81 score on a scale |
| SCP Plus Intervention | Change in Caregiver Coping Skills | Post-test | 96 score on a scale |
| SCP Plus Intervention | Change in Caregiver Coping Skills | 6-month Follow up | 79 score on a scale |
| Services as Usual | Change in Caregiver Coping Skills | Pre-test | 73 score on a scale |
| Services as Usual | Change in Caregiver Coping Skills | Post-test | 82 score on a scale |
| Services as Usual | Change in Caregiver Coping Skills | 6-month Follow up | 90 score on a scale |
Primary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| SCP Plus Intervention | Change in Caregiver Level of Satisfaction With Social Support | Pre-test | 3.5 score on a scale |
| SCP Plus Intervention | Change in Caregiver Level of Satisfaction With Social Support | Post-test | 4 score on a scale |
| SCP Plus Intervention | Change in Caregiver Level of Satisfaction With Social Support | 6-month follow up | 11.5 score on a scale |
| Services as Usual | Change in Caregiver Level of Satisfaction With Social Support | Pre-test | 9 score on a scale |
| Services as Usual | Change in Caregiver Level of Satisfaction With Social Support | Post-test | 12 score on a scale |
| Services as Usual | Change in Caregiver Level of Satisfaction With Social Support | 6-month follow up | 12 score on a scale |