Back to resultsGamePlan4Care: Online Support for Family Caregivers (GP4C)
Primary Purpose
Dementia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GamePlan4Care
Resources4Care
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring Caregiving, Skills-training
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
Sites / Locations
- Alzheimer's TexasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GamePlan4Care (GP4C)
Resources4Care (R4C)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Change from Baseline Depression at 6 months
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.
Change from Baseline Self-rated health at 6 months
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).
Change from Baseline Social Support at 6 months
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.
Change from Baseline Interaction with Health Care Providers at 6 months
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.
Secondary Outcome Measures
Change from Baseline Caregiver stress at 6 months
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.
Change from baseline reported positive aspects of caregiving at 6 months
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.
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 :
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).
Program evaluation of GP4C/R4C
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.
Full Information
NCT ID
NCT04540198
First Posted
January 2, 2019
Last Updated
August 15, 2022
Sponsor
Baylor Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04540198
Brief Title
GamePlan4Care: Online Support for Family Caregivers
Acronym
GP4C
Official Title
GamePlan4Care: Web-based Delivery System for REACH II
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baylor Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
Keywords
Caregiving, Skills-training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GamePlan4Care (GP4C)
Arm Type
Experimental
Arm Description
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.
Arm Title
Resources4Care (R4C)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
GamePlan4Care
Intervention Description
GamePlan4Care; Experimental
Intervention Type
Behavioral
Intervention Name(s)
Resources4Care
Intervention Description
R4C; Active Comparator
Primary Outcome Measure Information:
Title
Change from Baseline Caregiving Burden at 6 months
Description
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.
Time Frame
Baseline and six months
Title
Change from Baseline Depression at 6 months
Description
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.
Time Frame
Baseline and six months
Title
Change from Baseline Self-rated health at 6 months
Description
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).
Time Frame
Baseline and six months
Title
Change from Baseline Social Support at 6 months
Description
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.
Time Frame
Baseline and six months
Title
Change from Baseline Interaction with Health Care Providers at 6 months
Description
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.
Time Frame
Baseline and six months
Secondary Outcome Measure Information:
Title
Change from Baseline Caregiver stress at 6 months
Description
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.
Time Frame
Baseline and six months
Title
Change from baseline reported positive aspects of caregiving at 6 months
Description
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.
Time Frame
Baseline and six months
Title
Change from baseline neuropsychiatric symptoms in Care-recipient/corresponding caregiver distress at 6 months
Description
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).
Time Frame
At Baseline
Title
Program evaluation of GP4C/R4C
Description
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.
Time Frame
At six months only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alan Stevens, PhD
Phone
254-771-4880
Email
Alan.Stevens@bswhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Reese
Phone
2144907175
Email
Jordan.Reese@BSWHealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan B Stevens, PhD
Organizational Affiliation
Baylor Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alzheimer's Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
GamePlan4Care: Online Support for Family Caregivers
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