Dementia, Dementia Alzheimers, Dementia Frontal, Dementia Frontotemporal, Dementia, HIV, Dementia in Parkinsons Disease, Dementia, Lewy Body, Dementia, Mixed, Dementia, Multi-Infarct, Dementia of Alzheimer Type, Dementia, Vascular, Depression, Health Care Utilization, Loneliness, Self Efficacy, Social Isolation, Stress, Psychological
Conditions
Keywords
Caregiver, Caregiving
Brief summary
Rural caregivers face challenges of geographic isolation and lower health care access and quality. Many rural dementia caregivers experience serious health consequences due to caregiving responsibilities that can limit their ability to maintain their caregiving role. Thus, there is a pressing need for effective, scalable, and accessible programs to support rural dementia caregivers. Online programs offer a convenient and readily translatable option for program delivery because they can be accessed by caregivers in the home and at the convenience of the user. Building Better Caregivers is an online 6-week, interactive, small-group self-management, social support, and skills-building workshop developed for caregivers of individuals with Alzheimer's disease or related dementia. The investigators will conduct a hybrid effectiveness-implementation randomized controlled trial that will enroll and randomize 640 rural dementia caregivers into two groups: the intervention (workshop) group and the attention control group. Caregivers will be recruited throughout the United States. Primary outcomes will be caregiver stress and depressive symptoms. The investigators hypothesize that stress scores and depressive symptoms will be significantly improved at 12 months in the intervention group versus control group. The investigators will also identify key strengths (facilitators) and weaknesses (barriers) of workshop implementation. The investigators will use the RE-AIM implementation framework and a mixed methods approach to identify implementation characteristics pertinent to both caregivers and rural community organizations. If the Building Better Caregivers workshop is proven to be effective, this research has the potential to open new research horizons, particularly on how to reach and effectively support isolated dementia caregivers in rural areas with an intervention that is scalable, even in low-resourced settings. If the workshop can achieve its goals with rural dementia caregivers, some of those most isolated, it would also be expected to be scalable in other low-resourced settings (e.g., in urban or suburban environments).
Interventions
BEHAVIORALBuilding Better Caregivers Workshop
Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require real time attendance at pre-determined times.
BEHAVIORALAttention Control
Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.
Sponsors
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 years or older * Caring for person with dementia * Able to read and write in English * Able to access the internet * Providing care for ≥ 10 hours per week * Reporting a minimum stress level of 4 or more on a 10-point scale * Living in rural area of United States (self-identify or zip code is a Rural Urban Commuting Area Codes (RUCA) defined rural area)
Exclusion criteria
* Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Personal Health Questionnaire Depression (PHQ-8) Scale Score | 12 months | Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome. |
| Visual Numeric Stress Scale | 12 months | A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Caregiver Self-Efficacy Scale Score | 12 months | Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome. |
| Zarit Burden Interview-12 (ZBI-12) Scale Score | 12 months | Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome. |
| Caregiver Self-rated General Health Score | 12 months | Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome. |
| Visual Numeric Stress Scale Score | 6 months | A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome. |
| Lubben Social Isolation Scale Score | 12 months | Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome. |
| Caregiver Health Care Utilization | 12 months | 3-items measuring days of overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome. Scores range from 0-180. |
| Person With Dementia General Health Score as Reported by Caregiver | 12 months | Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome. |
| UCLA Loneliness Scale Score | 12 months | UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome. |
| Personal Health Questionnaire Depression (PHQ-8) Scale Score | 6 months | Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Building Better Caregivers Workshop Group The Building Better Caregivers Workshop is a 6-week online small group workshop. Participants received self-management and caregiving skills-building training and social support. They also received a workbook to keep. | 304 |
| Attention Control Group Attention control group participants received two 15-30 minutes phone calls and a handbook on dementia and caregiver resources. | 114 |
| Total | 418 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administratively removed prior to group delivery: unable to verify identify, duplicate, PLWD death | 4 | 5 |
| Overall Study | Lost to Follow-up | 27 | 7 |
| Overall Study | Planned study completion at 6-months. 2 final cohorts initiated with known follow up of 6 months. | 68 | 29 |
| Overall Study | Withdrawal by Subject | 9 | 4 |
Baseline characteristics
| Characteristic | Attention Control Group | Total | Building Better Caregivers Workshop Group |
|---|---|---|---|
| Age, Continuous | 63.53 years STANDARD_DEVIATION 10.57 | 62.26 years STANDARD_DEVIATION 11.24 | 61.79 years STANDARD_DEVIATION 11.47 |
| Caregiver Self-Efficacy | 5.1 units on a scale STANDARD_DEVIATION 1.8 | 5.2 units on a scale STANDARD_DEVIATION 1.8 | 5.2 units on a scale STANDARD_DEVIATION 1.8 |
| Healthcare Utilization | 0.46 days STANDARD_DEVIATION 1.9 | 0.3 days STANDARD_DEVIATION 1.2 | 0.23 days STANDARD_DEVIATION 0.9 |
| Loneliness | 6.0 units on a scale STANDARD_DEVIATION 1.9 | 6.0 units on a scale STANDARD_DEVIATION 2 | 6.0 units on a scale STANDARD_DEVIATION 2 |
| Person with Dementia General Health (caregiver reported) | 3.7 units on a scale STANDARD_DEVIATION 1.1 | 3.7 units on a scale STANDARD_DEVIATION 1 | 3.7 units on a scale STANDARD_DEVIATION 1 |
| PHQ-8 | 5.9 units on a scale STANDARD_DEVIATION 4.7 | 5.5 units on a scale STANDARD_DEVIATION 4.5 | 5.3 units on a scale STANDARD_DEVIATION 4.4 |
| Race/Ethnicity, Customized American Indian/Native American/Alaska Native | 4 Participants | 8 Participants | 4 Participants |
| Race/Ethnicity, Customized Asian/Asian American | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 4 Participants | 18 Participants | 14 Participants |
| Race/Ethnicity, Customized Hispanic/Latino | 6 Participants | 17 Participants | 11 Participants |
| Race/Ethnicity, Customized More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Unknown or not reported | 2 Participants | 7 Participants | 5 Participants |
| Race/Ethnicity, Customized White | 96 Participants | 359 Participants | 263 Participants |
| Region of Enrollment United States | 114 participants | 418 participants | 304 participants |
| Self-Rated General Health | 2.6 units on a scale STANDARD_DEVIATION 0.8 | 2.5 units on a scale STANDARD_DEVIATION 0.9 | 2.5 units on a scale STANDARD_DEVIATION 0.9 |
| Sex/Gender, Customized Sex Female | 94 Participants | 352 Participants | 258 Participants |
| Sex/Gender, Customized Sex Male | 20 Participants | 62 Participants | 42 Participants |
| Sex/Gender, Customized Sex Prefers not to identify | 0 Participants | 4 Participants | 4 Participants |
| Social Isolation | 13.4 units on a scale STANDARD_DEVIATION 5.7 | 13.5 units on a scale STANDARD_DEVIATION 5.6 | 13.5 units on a scale STANDARD_DEVIATION 5.6 |
| Stress | 6.8 units on a scale STANDARD_DEVIATION 1.8 | 6.6 units on a scale STANDARD_DEVIATION 1.8 | 6.5 units on a scale STANDARD_DEVIATION 1.8 |
| Zarit Care Burden | 22.6 units on a scale STANDARD_DEVIATION 7.7 | 22.8 units on a scale STANDARD_DEVIATION 8.3 | 22.9 units on a scale STANDARD_DEVIATION 8.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 1 / 114 |
| other Total, other adverse events | 0 / 304 | 0 / 114 |
| serious Total, serious adverse events | 0 / 304 | 1 / 114 |
Outcome results
Primary
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Personal Health Questionnaire Depression (PHQ-8) Scale Score | 5.6 units on a scale | Standard Deviation 4.1 |
| Attention Control Group | Personal Health Questionnaire Depression (PHQ-8) Scale Score | 5.8 units on a scale | Standard Deviation 4.4 |
Primary
Visual Numeric Stress Scale
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Visual Numeric Stress Scale | 5.9 score on a scale | Standard Deviation 2.2 |
| Attention Control Group | Visual Numeric Stress Scale | 6.0 score on a scale | Standard Deviation 2.1 |
Secondary
Caregiver Health Care Utilization
3-items measuring days of overnight hospitalizations, nursing home or other long-term care facility use, and hospital emergency room visits from the Health and Retirement Study, modified time frame from self-report for past 12 months to self-report for past 6 months; scored as single items; with higher scores indicating worse outcome. Scores range from 0-180.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Caregiver Health Care Utilization | 0.30 days | Standard Deviation 1.3 |
| Attention Control Group | Caregiver Health Care Utilization | 0.84 days | Standard Deviation 3.1 |
Secondary
Caregiver Self-rated General Health Score
Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 self-rated general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Caregiver Self-rated General Health Score | 2.6 units on a scale | Standard Deviation 0.9 |
| Attention Control Group | Caregiver Self-rated General Health Score | 2.7 units on a scale | Standard Deviation 0.9 |
Secondary
Lubben Social Isolation Scale Score
Lubben Social isolation scale (6-items). The scale score is calculated by summing each item to produce a total score between 0 and 30, with lower scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Lubben Social Isolation Scale Score | 13.1 units on a scale | Standard Deviation 5.7 |
| Attention Control Group | Lubben Social Isolation Scale Score | 13.8 units on a scale | Standard Deviation 5.1 |
Secondary
Personal Health Questionnaire Depression (PHQ-8) Scale Score
Personal Health Questionnaire Depression (PHQ-8) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Personal Health Questionnaire Depression (PHQ-8) Scale Score | 5.7 units on a scale | Standard Deviation 4.6 |
| Attention Control Group | Personal Health Questionnaire Depression (PHQ-8) Scale Score | 7.1 units on a scale | Standard Deviation 5.4 |
Secondary
Person With Dementia General Health Score as Reported by Caregiver
Patient-Reported Outcomes Measurement Information System (PROMIS) measure SF-1 caregiver-reported general health single item. The scale score ranges from 1 to 5, with higher scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Person With Dementia General Health Score as Reported by Caregiver | 3.8 units on a scale | Standard Deviation 1 |
| Attention Control Group | Person With Dementia General Health Score as Reported by Caregiver | 3.8 units on a scale | Standard Deviation 1 |
Secondary
Short Caregiver Self-Efficacy Scale Score
Short Caregiver Self-Efficacy scale (8-items). The scale scores is calculated by taking the mean of the items to produce a total score between 1 and 10, with higher scores indicating better outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Short Caregiver Self-Efficacy Scale Score | 5.4 units on a scale | Standard Deviation 2 |
| Attention Control Group | Short Caregiver Self-Efficacy Scale Score | 5.1 units on a scale | Standard Deviation 1.6 |
Secondary
UCLA Loneliness Scale Score
UCLA loneliness scale (3-items). The scale score is calculated by summing each item to produce a total score between 3 and 9, with higher scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | UCLA Loneliness Scale Score | 5.9 units on a scale | Standard Deviation 2 |
| Attention Control Group | UCLA Loneliness Scale Score | 5.4 units on a scale | Standard Deviation 1.9 |
Secondary
Visual Numeric Stress Scale Score
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Visual Numeric Stress Scale Score | 6.0 units on a scale | Standard Deviation 2.2 |
| Attention Control Group | Visual Numeric Stress Scale Score | 5.9 units on a scale | Standard Deviation 2.2 |
Secondary
Zarit Burden Interview-12 (ZBI-12) Scale Score
Short form of the Zarit Burden Interview-12 (ZBI-12) scale (12-items). The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating worse outcome.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Building Better Caregivers Workshop Group | Zarit Burden Interview-12 (ZBI-12) Scale Score | 21.9 units on a scale | Standard Deviation 9 |
| Attention Control Group | Zarit Burden Interview-12 (ZBI-12) Scale Score | 23.4 units on a scale | Standard Deviation 7.3 |