Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
418 participants
INTERVENTIONAL
2020-06-05
2023-10-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Self- Care TALK Study - Promoting Alzheimer's Disease (AD) Spousal Caregiver Health
NCT00646074
Self-Management Intervention: Considering Needs & Preferences of Dementia Caregivers (Caregiver Career Study)
NCT04603482
Brain Health Project for Korean American Dementia Caregivers
NCT06928454
In-Home Technology for Caregivers of People With Dementia and Mild Cognitive Impairment: Rural Homes
NCT05159583
Telephone-delivered Mindfulness Intervention for African American Dementia Caregivers
NCT04058886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Building 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.
Attention Control Group
Participants will be offered the online workshop after the 12 month trial is completed if they so desire.
Attention 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Building 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.
Attention 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
University of California, San Francisco
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Veronica Yank, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Francisco
San Francisco, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Santoyo-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.
Santoyo-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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan: Protocol and SAP
Document Type: Study Protocol: Revised protocol (randomization plan subsection)
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.