N/A
N=418
Rural Dementia Caregiver Project
Depression · Stress, Psychological · Self Efficacy · Loneliness · Social Isolation
Bottom Line
View on ClinicalTrials.gov: NCT04428112 ↗Enrolled (actual)
418
Serious AEs
0.2%
Results posted
Jul 2025
Primary outcome: Primary: Personal Health Questionnaire Depression (PHQ-8) Scale Score — 5.6; 5.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Building Better Caregivers Workshop (Behavioral); Attention Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Personal Health Questionnaire Depression (PHQ-8) Scale Score |
5.7; 7.1 | — |
| PRIMARY Visual Numeric Stress Scale |
5.9; 6.0 | — |
| SECONDARY Personal Health Questionnaire Depression (PHQ-8) Scale Score |
5.7; 7.1 | — |
| SECONDARY Visual Numeric Stress Scale Score |
6.0; 5.9 | — |
| SECONDARY Short Caregiver Self-Efficacy Scale Score |
5.4; 5.1 | — |
| SECONDARY Zarit Burden Interview-12 (ZBI-12) Scale Score |
21.9; 23.4 | — |
| SECONDARY Caregiver Self-rated General Health Score |
2.6; 2.7 | — |
| SECONDARY UCLA Loneliness Scale Score |
5.9; 5.4 | — |
| SECONDARY Lubben Social Isolation Scale Score |
13.1; 13.8 | — |
| SECONDARY Caregiver Health Care Utilization |
0.30; 0.84 | — |
| SECONDARY Person With Dementia General Health Score as Reported by Caregiver |
3.8; 3.8 | — |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04428112). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.