Clinical trial NCT04540198: GamePlan4Care: Online Support for Family Caregivers
Official title: GamePlan4Care: Web-based Delivery System for REACH II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Keywords: Caregiving
Skills-training
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline Caregiving Burden at 6 months
timeFrame: Baseline and six months
measure: Change from Baseline Depression at 6 months
timeFrame: Baseline and six months
measure: Change from Baseline Self-rated health at 6 months
timeFrame: Baseline and six months
measure: Change from Baseline Social Support at 6 months
timeFrame: Baseline and six months
measure: Change from Baseline Interaction with Health Care Providers at 6 months
timeFrame: Baseline and six months
Secondary outcomes:
measure: Change from Baseline Caregiver stress at 6 months
timeFrame: Baseline and six months
measure: Change from baseline reported positive aspects of caregiving at 6 months
timeFrame: Baseline and six months
measure: Change from baseline neuropsychiatric symptoms in Care-recipient/corresponding caregiver distress at 6 months
timeFrame: At Baseline
measure: Program evaluation of GP4C/R4C
timeFrame: At six months only
Other outcomes:
Locations:
city: Austin
country: United States
facility: Alzheimer's Texas
state: Texas
Study officials:
affiliation: Baylor Research Institute
name: Alan B Stevens, PhD
role: PRINCIPAL_INVESTIGATOR
References: