GamePlan4Care: Online Support for Family Caregivers

NCT04540198 | Completed Results

• 2 other identifiers: 018-622R01AG061973-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia

Keywords

Caregiving; Skills-training

Outcome Measures

Primary Outcomes (3)

• Change From Baseline Caregiving Burden at 6 Months

  A 12-item version of the Zarit Caregiver Burden Interview. The Zarit Caregiver Burden Interview (ZBI) is an assessment tool for evaluating caregiver burden. The ZBI consists of 12 items representing a statement related to some aspect of perceived burden. Respondents (i.e., caregivers) rate each item ranging 0 (=never) to 4 (=nearly always). Total ZBI score is the summation of 12 items ranging from 0 to 48. Higher scores indicate greater burden.

  Baseline and six months

• Change From Baseline Depression at 6 Months

  Levels of depressed symptoms: A 10-item Center for Epidemiological Studies Depression Scale (CES-D) is scored from zero (= rarely or none of the time) to three (= most or all of the time). Two items are reverse scored. The total score ranges from zero to 30 indicating that higher scores are higher levels of depressive symptoms.

  Baseline and six months

• Change From Baseline Social Support at 6 Months

  Assessment of availability of support and satisfaction with support from others: Two subscales of the Social Provisions Scale (SPS), Reliable Alliance and Guidance, assessed the availability of social support and satisfaction with support received from others. Each subscale has four items. Each question is scored from one (=strongly disagree) to four (=strongly agree). Each subscale contains two questions that are reverse-scored. Ranging from four to 16, the higher total scores indicate higher levels of reliable alliance and guidance.

  Baseline and six months

Secondary Outcomes (3)

• Change From Baseline Caregiver Stress at 6 Months

  Baseline and six months

• Change From Baseline Reported Positive Aspects of Caregiving at 6 Months

  Baseline and six months

• Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months

  At Baseline and 6 months

Study Arms (2)

GamePlan4Care (GP4C)

EXPERIMENTAL

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.

Behavioral: GamePlan4Care

Resources4Care (R4C)

ACTIVE COMPARATOR

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.

Behavioral: Resources4Care

Interventions

GamePlan4Care BEHAVIORAL

GamePlan4Care; Experimental

GamePlan4Care (GP4C)

Resources4Care BEHAVIORAL

R4C; Active Comparator

Resources4Care (R4C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Baylor Research Institute: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Alzheimer's Texas

Austin, Texas, 78731, United States

Location

Related Publications (1)

• 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.

  PMID: 41085219 DERIVED

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Alan Stevens
• Organization: Baylor Scott & White Health Research Institute

alan.stevens@bswhealth.org

254-215-9885

Study Officials

• Alan B Stevens, PhD

  Baylor Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2019
• First Posted: September 7, 2020
• Study Start: October 29, 2019
• Primary Completion: June 16, 2023
• Study Completion: May 31, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be made available after a reasonable time has elapsed to allow the original investigators time to publish results. Upon completion of all planned analyses, data will be archived according to NIH policy.

Locations

US (1)