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Clinical Trials/NCT04540198
NCT04540198
Completed
Not Applicable

GamePlan4Care: Web-based Delivery System for REACH II

Baylor Research Institute1 site in 1 country240 target enrollmentOctober 29, 2019
ConditionsDementia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dementia
Sponsor
Baylor Research Institute
Enrollment
240
Locations
1
Primary Endpoint
Change From Baseline Caregiving Burden at 6 Months
Status
Completed
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 29, 2019
End Date
May 31, 2024
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Change From Baseline Caregiving Burden at 6 Months

Time Frame: Baseline and six 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.

Change From Baseline Depression at 6 Months

Time Frame: Baseline and six 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.

Change From Baseline Social Support at 6 Months

Time Frame: Baseline and six 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.

Secondary Outcomes

  • 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 Sites (1)

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