GamePlan4Care: Online Support for Family Caregivers (GP4C)

GamePlan4Care: Web-based Delivery System for REACH II

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.

Study Overview

• Status: Completed
• Conditions: Dementia
• Intervention / Treatment: Behavioral: GamePlan4Care; Behavioral: Resources4Care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78731
      • Alzheimer's Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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").
• The family member, named as the care recipient (CR) in this proposal, must be diagnosed with AD/ADRD (self-report from the caregiver accepted) and is experiencing signs of dementia as verified by the family caregiver on the AD8 informant interview. A score of 2 or greater is the inclusion criteria.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: GamePlan4Care; GamePlan4Care; Experimental
Active Comparator: 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.	Behavioral: Resources4Care; R4C; Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline Caregiver Stress at 6 Months	Assessment of levels of stress: Perceived Stress Scale (PSS) was used to assess the degree of stress individuals experienced, using 10 items. Each item is scored from zero to four, with a total score range of zero to 40. Four items were scored reversely. Higher total scores indicate greater perceived stress.	Baseline and six months
Change From Baseline Reported Positive Aspects of Caregiving at 6 Months	Assessment of favorable aspects of caregiving experiences: The PAC was measured with 11 items of the favorable aspects of caregiving experience. Each question is scored from zero to four with a total score ranging from zero to 44. Higher scores indicate higher levels of positive feelings from caregiving.	Baseline and six months
Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months	Presence and severity of neuropsychiatric symptoms and levels of relevant caregiving distress : The NPI-Q measures the presence, severity and distress ratings of 12 neuropsychiatric symptoms in patients with dementia. Presence of each symptom and distress ratings for each symptom are reported as well as the total sum of dementia behaviors and distress scores for each symptom. Each dementia behavior was scored as a binary change score (yes/no). Distress is scored from zero to five with higher scores indicating higher levels of distress.	At Baseline and 6 months

Collaborators and Investigators

• Sponsor: Baylor Research Institute
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Alan B Stevens, PhD, Baylor Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2019
• Primary Completion (Actual): June 16, 2023
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: January 2, 2019
• First Submitted That Met QC Criteria: August 31, 2020
• First Posted (Actual): September 7, 2020

Study Record Updates

• Last Update Posted (Estimated): August 28, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Caregiving; Skills-training
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 018-622; R01AG061973-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD for all the primary and secondary outcomes will be shared with outside investigators, after review and approval for data use requests. Data for potential collaborators will be compiled as de-identified datasets to safeguard participant confidentiality. We will make a standardized dataset available to approved investigators, based on a subset of data from the study database; this dataset will be compiled and available after completion of the the study.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No