Rural Dementia Caregiver Project

NCT ID: NCT04428112

Last Updated: 2025-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

418 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-05

Study Completion Date

2023-10-16

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Building Better Caregivers Workshop

Intervention Type 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 Group

Participants will be offered the online workshop after the 12 month trial is completed if they so desire.

Group Type ACTIVE_COMPARATOR

Attention Control

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronica Yank, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 41164840 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37897201 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36057375 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan: Protocol and SAP

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Document Type: Study Protocol: Revised protocol (randomization plan subsection)

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Document Type: Informed Consent Form

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Other Identifiers

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5R01AG057855-02

Identifier Type: NIH

Identifier Source: secondary_id

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3R01AG057855-02S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

18-25814

Identifier Type: -

Identifier Source: org_study_id

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