GamePlan4Care: Online Support for Family Caregivers

NCT ID: NCT04540198

Last Updated: 2025-08-28

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-29

Study Completion Date

2024-05-31

Brief Summary

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As the population of older adults grows, almost doubling in size from 2012 to 2040, so too will the need for family caregiving. Caregiving can lead to negative psychosocial outcomes such as depression, anxiety, and burden; social isolation and family conflict: financial strain due to costs of care; and some caregivers also experience negative health consequences. This project will test the value of GamePlan4Care (GP4C) an evidence-based, internet-enabled system capable of providing immediate, tailored education and skills training to caregivers who can access live support from a DCS via phone or web-based video.

Detailed Description

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Daily care and supervision of a person living with dementia (PWD) has been defined as "intense caregiving" and is associated with significant daily burdens and an overall threat to the caregiver's quality of life. Despite evidence suggesting that negative consequence can be remediated with community-based supports, those services remain allusive to caregivers due to the systemic challenges of turning interventions into services. This study is based on a practical approach of applying technology to an existing evidence-based intervention, Resources for Enhancing Alzheimer's Caregiver Health II (REACH II), refined with real-world user feedback and rigorously tested with the goal of creating an online family caregiver support system that has the potential of both scalability and sustainability. This two-group randomized controlled trial will compare the relative impact of GP4C to an education-based online site called Resources4Care (R4C) on a wide range of family caregiver outcomes. Family caregivers will be randomized to one of the two conditions and will complete an assessment battery at baseline and at the 6-month follow-up.

Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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GamePlan4Care (GP4C)

Participants in this arm will have access to full functionality and content of the online system GamePlan4Care (GP4C) including educational resources, skills training, and support tailored to their unique caregiving needs. Additional individualized feedback will be automatically generated based on responses to online questions and will include links to relevant site educational/skill-building content. Participants will be assigned a Dementia Care Specialist who will facilitate caregiver interactions with the online material and provide skills training via telephone or web-video conference. Study participants assigned to GP4C will receive 9 automated emails and 4 phone calls over a 6-month period.

Group Type EXPERIMENTAL

GamePlan4Care

Intervention Type BEHAVIORAL

GamePlan4Care; Experimental

Resources4Care (R4C)

Participants in this arm will receive access to Resources4Care (R4C), a feature-limited version GamePlan4Care system. R4C will serve as an online hub for articles and videos about Alzheimer's disease and dementia. Educational topics will included information on: 1) Alzheimer's Disease \& Dementia, 2) Caregiving, 3) Caregiver Stress and 4) Home Safety. R4C will present a page on each topic with active links to two additional online sources on the same topic. Study participants assigned to R4C will receive two emails from their DCS encouraging the caregiver to review specific education materials. Each email will be followed by brief "check-in" calls (15-min each) at three months and five months after randomization.

Group Type ACTIVE_COMPARATOR

Resources4Care

Intervention Type BEHAVIORAL

R4C; Active Comparator

Interventions

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GamePlan4Care

GamePlan4Care; Experimental

Intervention Type BEHAVIORAL

Resources4Care

R4C; Active Comparator

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Must be age 18 years or older
* Providing at least 8 hours of weekly care and/or supervision (on average) for a friend or family member with a self-reported diagnosis of Alzheimer's disease or a related dementia. Family will be subjectively determined by the caregiver to enable a broader definition of a" "family" member often found in minority communities (e.g., a person not related by blood but who serves in the role of an "aunt" or "grandchild").
* Must demonstrate access to a home computer with internet access to research staff and report using the computer to access the internet at least three times per week, on average.
* English-speaking caregivers
* Must reside within the recruitment area (Target counties within Texas: Bastrop, Bell, Blanco, Burnet, Caldwell, Coryell, Fayette, Hamilton, Hays, Lampasas, Lee, Llano, Milam, Mills, San Saba, Travis, Williamson)

Exclusion Criteria

* Current participation in another caregiving evidence-based program
* Previous participation in usability testing for current system development
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

Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alan B Stevens, PhD

Role: PRINCIPAL_INVESTIGATOR

Baylor Research Institute

Locations

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Alzheimer's Texas

Austin, Texas, United States

Site Status

Countries

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United States

References

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Stevens AB, Cho J, Birchfield T, Reese J, Han G, Thorud JL, Ory MG. A randomized trial of two online platforms for dementia family caregivers: GamePlan4Care and Resources4Care. Alzheimers Dement. 2025 Oct;21(10):e70690. doi: 10.1002/alz.70690.

Reference Type DERIVED
PMID: 41085219 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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R01AG061973-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

018-622

Identifier Type: -

Identifier Source: org_study_id

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