Rural Dementia Caregiver Project

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT04428112
Status
Completed

Conditions

  • Dementia
  • Dementia Alzheimers
  • Dementia Frontal
  • Dementia Frontotemporal
  • Dementia in Parkinsons Disease
  • Dementia of Alzheimer Type
  • Dementia, HIV
  • Dementia, Lewy Body
  • Dementia, Mixed
  • Dementia, Multi-Infarct
  • Dementia, Vascular
  • Depression
  • Health Care Utilization
  • Loneliness
  • Self Efficacy
  • Social Isolation
  • Stress, Psychological

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Building Better Caregivers Workshop — BEHAVIORAL
    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.
  • Attention Control — BEHAVIORAL
    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.

Study Details

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).

Key Dates

Start date
Jun 5, 2020
Status verified
Jun 2025
Primary completion
Oct 16, 2023
Completion
Oct 16, 2023

Study Design

Enrollment
418 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Building Better Caregivers Workshop Group
    Building Better Caregivers Workshop is a 6-week online self-management and skills building workshop. Participants receive the online workshop as soon as possible after randomization.
  • Active Comparator: Attention Control Group
    Participants will be offered the online workshop after the 12 month trial is completed if they so desire.

Primary Outcome Measure

Personal Health Questionnaire Depression (PHQ-8) Scale Score [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94118-

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