Rural Dementia Caregiver Project
Evaluating the Effectiveness of an Online Small-Group Self-Management Workshop for Rural Caregivers of Individuals With Alzheimer's Disease and Related Dementias
3 other identifiers
interventional
418
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jun 2020
Typical duration for not_applicable depression
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2020
CompletedFirst Submitted
Initial submission to the registry
June 9, 2020
CompletedFirst Posted
Study publicly available on registry
June 11, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 16, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2023
CompletedResults Posted
Study results publicly available
July 17, 2025
CompletedJuly 17, 2025
June 1, 2025
3.4 years
June 9, 2020
December 3, 2024
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
12 months
Visual Numeric Stress Scale
A visual numeric stress scale. The scale score ranges from 0 to 10, with higher score indicating worse outcome.
12 months
Secondary Outcomes (9)
Personal Health Questionnaire Depression (PHQ-8) Scale Score
6 months
Visual Numeric Stress Scale Score
6 months
Short Caregiver Self-Efficacy Scale Score
12 months
Zarit Burden Interview-12 (ZBI-12) Scale Score
12 months
Caregiver Self-rated General Health Score
12 months
- +4 more secondary outcomes
Study Arms (2)
Building Better Caregivers Workshop Group
EXPERIMENTALBuilding 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.
Attention Control Group
ACTIVE COMPARATORParticipants will be offered the online workshop after the 12 month trial is completed if they so desire.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Have an anticipated inability to complete the 12-month follow-up (e.g., planned travel)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California, San Francisco
San Francisco, California, 94118, United States
Related Publications (3)
Santoyo-Olsson J, Covinsky KE, Cheng J, Gallagher Thompson D, Yank V. Utilization of home- and community-based services among rural family caregivers of persons with dementia: the role of the area deprivation index. Front Public Health. 2025 Oct 14;13:1688161. doi: 10.3389/fpubh.2025.1688161. eCollection 2025.
PMID: 41164840DERIVEDSantoyo-Olsson J, Covinsky KE, Chesla CA, Lorig K, Gallagher-Thompson D, Cheng J, Luzanilla M, Macias Romo E, Aguayo Ramirez G, Karliner L, Yank V. Predictors of Psychological Distress Among Rural Family/Friend Caregivers of People Living With Dementia in the United States: Consequences of the COVID-19 Pandemic. J Gerontol B Psychol Sci Soc Sci. 2024 Feb 1;79(2):gbad164. doi: 10.1093/geronb/gbad164.
PMID: 37897201DERIVEDSantoyo-Olsson J, Lorig K, Romo EM, Luzanilla M, Ramirez GA, Cheng J, Chesla C, Covinsky KE, Karliner L, Thompson DG, Fahrenwald N, Yank V. Study protocol for a hybrid effectiveness-implementation trial of the Building Better Caregivers online workshop for rural family/friend caregivers of people living with dementia. Contemp Clin Trials. 2022 Oct;121:106903. doi: 10.1016/j.cct.2022.106903. Epub 2022 Aug 31.
PMID: 36057375DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Randomization occurred 2 weeks before group delivery to allow for mailing of books and scheduling calls. During this run-in period 9 participants were administratively dropped: 4 in intervention group, due to death of person with dementia (2), being a duplicate (1), and inability to verify identity (1); 5 in control group, due to death of their person (3), death of caregiver in natural disaster (1), and being paid caregiver (1). Thus, the modified ITT analysis included 409 participants.
Results Point of Contact
- Title
- Dr. Veronica Yank
- Organization
- UCSF
Study Officials
- PRINCIPAL INVESTIGATOR
Veronica Yank, MD
University of California, San Francisco
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2020
First Posted
June 11, 2020
Study Start
June 5, 2020
Primary Completion
October 16, 2023
Study Completion
October 16, 2023
Last Updated
July 17, 2025
Results First Posted
July 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will become available beginning within 3 months of article publication and ending 5 years following article publication.
- Access Criteria
- The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).
The data to be shared will be individual participant data that underlie the results reported in published article(s), after deidentification (e.g., text, tables, figures, and appendices). The additional and related documents that will be available are study protocol and data dictionary. The data will become available beginning within 3 months of article publication and ending 5 years following article publication.The access criteria for the data to be shared will include researchers who provide a methodologically sound proposal in order to achieve aims in the approved proposal including performance of meta-analysis of individual participant data. Proposals should be directed to veronica.yank@ucsf.edu. To gain access, data requestors will need to sign a data access agreement. Data will be available for 5 years at a third party website (Link to be included later).