Trial Outcomes & Findings for GamePlan4Care: Online Support for Family Caregivers (NCT NCT04540198)
NCT ID: NCT04540198
Last Updated: 2025-08-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
240 participants
Primary outcome timeframe
Baseline and six months
Results posted on
2025-08-28
Participant Flow
Participants were recruited from various locations in Central Texas, including community-based organizations like Area Agencies on Aging and Alzheimer's nonprofits. Health system providers also referred family caregivers of patients diagnosed with dementia. This multi-faceted approach aimed to reach a diverse population of caregivers, enhancing the study's representativeness and engagement.
After participants expressed interest, the study involved a screening process where research staff conducted phone calls to assess eligibility. Several caregivers were excluded for reasons such as not providing sufficient care hours, lacking internet access, currently engaging in other support programs, or no diagnosis of Alzheimer's disease or related dementia.
Participant milestones
| Measure |
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.
GamePlan4Care: GamePlan4Care; Experimental
|
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
120
|
|
Overall Study
COMPLETED
|
79
|
88
|
|
Overall Study
NOT COMPLETED
|
41
|
32
|
Reasons for withdrawal
| Measure |
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.
GamePlan4Care: GamePlan4Care; Experimental
|
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
25
|
23
|
|
Overall Study
Withdrawal by Subject
|
15
|
9
|
|
Overall Study
Discontinued
|
1
|
0
|
Baseline Characteristics
GamePlan4Care: Online Support for Family Caregivers
Baseline characteristics by cohort
| Measure |
GamePlan4Care (GP4C)
n=120 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=120 Participants
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.
Resources4Care: R4C; Active Comparator
|
Total
n=240 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.79 years
STANDARD_DEVIATION 12.83 • n=5 Participants
|
64.73 years
STANDARD_DEVIATION 11.28 • n=7 Participants
|
64.76 years
STANDARD_DEVIATION 12.06 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
109 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
AD8 - Ascertain Dementia 8
|
7.44 Score on a Scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
7.63 Score on a Scale
STANDARD_DEVIATION 0.74 • n=7 Participants
|
7.54 Score on a Scale
STANDARD_DEVIATION 0.97 • n=5 Participants
|
|
Neuropsychiatric Inventory-Questionnaire (NPI-Q) Behavior
|
6.98 Score on Scale
STANDARD_DEVIATION 2.74 • n=5 Participants
|
7.04 Score on Scale
STANDARD_DEVIATION 2.63 • n=7 Participants
|
7.01 Score on Scale
STANDARD_DEVIATION 2.68 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and six monthsA 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Caregiving Burden at 6 Months
|
-3.00 score on a scale
Standard Deviation 6.01
|
-2.75 score on a scale
Standard Deviation 5.82
|
PRIMARY outcome
Timeframe: Baseline and six monthsLevels 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Depression at 6 Months
|
-1.57 score on a scale
Standard Deviation 5.97
|
-0.57 score on a scale
Standard Deviation 5.43
|
PRIMARY outcome
Timeframe: Baseline and six monthsAssessment 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Social Support at 6 Months
SPS Reliable Alliance
|
0.13 score on a scale
Standard Deviation 2.56
|
0.01 score on a scale
Standard Deviation 2.51
|
|
Change From Baseline Social Support at 6 Months
SPS Guidance
|
0.42 score on a scale
Standard Deviation 1.96
|
0.46 score on a scale
Standard Deviation 2.33
|
SECONDARY outcome
Timeframe: Baseline and six monthsAssessment 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Caregiver Stress at 6 Months
|
-1.41 score on a scale
Standard Deviation 6.33
|
-1.22 score on a scale
Standard Deviation 5.64
|
SECONDARY outcome
Timeframe: Baseline and six monthsAssessment 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Reported Positive Aspects of Caregiving at 6 Months
|
1.95 score on a scale
Standard Deviation 7.42
|
1.35 score on a scale
Standard Deviation 5.75
|
SECONDARY outcome
Timeframe: At Baseline and 6 monthsPresence 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.
Outcome measures
| Measure |
GamePlan4Care (GP4C)
n=79 Participants
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.
GamePlan4Care: GamePlan4Care; Experimental
|
Resources4Care (R4C)
n=88 Participants
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.
Resources4Care: R4C; Active Comparator
|
|---|---|---|
|
Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months
|
-2.62 score on a scale
Standard Deviation 8.83
|
-1.53 score on a scale
Standard Deviation 7.50
|
Adverse Events
GamePlan4Care (GP4C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resources4Care (R4C)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alan Stevens
Baylor Scott & White Health Research Institute
Phone: 254-215-9885
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place