- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04540198
GamePlan4Care: Online Support for Family Caregivers (GP4C)
GamePlan4Care: Web-based Delivery System for REACH II
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Alan Stevens, PhD
- Phone Number: 254-771-4880
- Email: Alan.Stevens@bswhealth.org
Study Contact Backup
- Name: Jordan Reese
- Phone Number: 2144907175
- Email: Jordan.Reese@BSWHealth.org
Study Locations
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Texas
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Austin, Texas, United States, 78731
- Recruiting
- Alzheimer's Texas
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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: Factorial Assignment
- Masking: Double
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.
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GamePlan4Care; Experimental
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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.
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R4C; Active Comparator
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline and six months
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Change from Baseline Depression at 6 months
Time Frame: Baseline and six months
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Levels of depressed symptoms: A 10-item version of the Center for Epidemiological Studies Depression (CESD) Scale is an assessment tool for evaluating depression. Each item represents a statement for which respondents indicate how often in the past week they have felt that way from 0 (= rarely or none of the time) to 3 (= most or almost all of the time). Total score is the summation of 10 items ranging from 0 to 30. Higher scores indicate higher levels of depressed symptoms. |
Baseline and six months
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Change from Baseline Self-rated health at 6 months
Time Frame: Baseline and six months
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Assessment of perception of general health status A single item of self-rated health assess caregiver's perception on his/her own health from 0 (=excellent) to 4 (=poor). |
Baseline and six months
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Change from Baseline Social Support at 6 months
Time Frame: Baseline and six months
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Assessment of availability of support and satisfaction with support from others: Two constructs from Social Provision Scale (reliable alliance and guidance) are used to evaluate social support. Two constructs assess availability of support and satisfaction with support from others. Four items for each construct (total of 8 items) describe a statement for which respondents agree to what extent their relationships are with other people from 1 (= strongly disagree) to 4 (=strongly agree). A total score is the summation of 8 items ranging from 8 to 32. Higher scores indicate higher levels of social support. |
Baseline and six months
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Change from Baseline Interaction with Health Care Providers at 6 months
Time Frame: Baseline and six months
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Assessment of the frequency and experiences of medical care management and coordination for care-recipients: 9 items from the National Study of Caregiving (NSOC) ask about experiences and frequency of caregiver's interactions with care-recipients' health care providers. Each item represents a statement for which respondents indicate how often in the last 6 months they interact with health care providers/workers. |
Baseline and six months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Caregiver stress at 6 months
Time Frame: Baseline and six months
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Assessment of levels of stress: The Perceived Stress Scale (PSS) is an assessment tool for evaluating stress level. The PSS consists of 10 stress items. Each item represents how often in the last month respondents felt that way from 0 (=never) to 4 (=very often). A total score is the summation of 10 items ranging from 0 to 40. Higher scores indicate higher levels of stress. |
Baseline and six months
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Change from baseline reported positive aspects of caregiving at 6 months
Time Frame: Baseline and six months
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Assessment of favorable aspects of caregiving experiences: An 11-item of Positive Aspect of caregiving (PAC) is an assessment tool for evaluating favorable aspects of caregiving experiences. Each item represents a statement of mental or affective state related to caregiving experiences. Respondents rate to what extent the each statement corresponds to their mental or affective state ranging from 0 (=disagree a lot) to 4 (=agree a lot). A total score is the summation of 11 items ranging from 0 to 44. Higher scores indicate higher levels of positive experiences of caregiving. |
Baseline and six months
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Change from baseline neuropsychiatric symptoms in Care-recipient/corresponding caregiver distress at 6 months
Time Frame: At Baseline
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Presence and severity of neuropsychiatric symptoms and levels of relevant caregiving distress : Neuropsychiatric Inventory Questionnaire-Q (NPI-Q), a 12-item self-administered questionnaire (NPI-Q), completed by the caregivers about care-recipients for whom they care, is a tool to assess the presence and severity of 12 Neuropsychiatric Symptoms (NPS) in patients with dementia, as well as the caregiver's corresponding distress. Each item asks the presence (1=yes, 0=no), severity (1=mild, 2=moderate, 3=severe), and caregiving distress (0=not at all; 5=extreme or very severe). |
At Baseline
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Program evaluation of GP4C/R4C
Time Frame: At six months only
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Assessment of Attitude toward GP4C/R4C system: A 30-items of USE questionnaire will evaluate participant's attitude toward GP4C system. The USE questionnaire includes four areas: assess usefulness (8 items), ease of use (11 items), ease of learning (4 items), and satisfaction (7 items). Respondents rate agreement with the statements, ranging from strongly disagree (=1) to strongly agree (=7). Total scores are the summation of items on each area. Higher scores in each are indicate more useful, easier to use, easier to learn, and more satisfied on their experience. |
At six months only
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan B Stevens, PhD, Baylor Research Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 018-622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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