Rural Dementia Caregiver Project
- Conditions
- DepressionStress, PsychologicalDementia FrontotemporalLonelinessDementiaSelf EfficacySocial IsolationHealth Care UtilizationDementia, Multi-InfarctDementia, Lewy Body
- Registration Number
- NCT04428112
- Lead Sponsor
- University of California, San Francisco
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 418
- 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)
- Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
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.
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.
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco🇺🇸San Francisco, California, United States