Dementia
Conditions
Keywords
Caregiving, Skills-training
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.
Interventions
BEHAVIORALGamePlan4Care
GamePlan4Care; Experimental
BEHAVIORALResources4Care
R4C; Active Comparator
Sponsors
National Institute on Aging (NIA)
Baylor Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Caregiving Burden at 6 Months | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Caregiver Stress at 6 Months | Baseline and six months | Assessment 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. |
| Change From Baseline Reported Positive Aspects of Caregiving at 6 Months | Baseline and six months | Assessment 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. |
| Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months | At Baseline and 6 months | Presence 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 120 |
| 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 | 120 |
| Total | 240 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discontinued | 1 | 0 |
| Overall Study | Lost to Follow-up | 25 | 23 |
| Overall Study | Withdrawal by Subject | 15 | 9 |
Baseline characteristics
| Characteristic | Resources4Care (R4C) | GamePlan4Care (GP4C) | Total |
|---|---|---|---|
| AD8 - Ascertain Dementia 8 | 7.63 Score on a Scale STANDARD_DEVIATION 0.74 | 7.44 Score on a Scale STANDARD_DEVIATION 0.97 | 7.54 Score on a Scale STANDARD_DEVIATION 0.97 |
| Age, Continuous | 64.73 years STANDARD_DEVIATION 11.28 | 64.79 years STANDARD_DEVIATION 12.83 | 64.76 years STANDARD_DEVIATION 12.06 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 21 Participants | 11 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants | 109 Participants | 208 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Neuropsychiatric Inventory-Questionnaire (NPI-Q) Behavior | 7.04 Score on Scale STANDARD_DEVIATION 2.63 | 6.98 Score on Scale STANDARD_DEVIATION 2.74 | 7.01 Score on Scale STANDARD_DEVIATION 2.68 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 10 Participants | 21 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 101 Participants | 101 Participants | 202 Participants |
| Sex: Female, Male Female | 95 Participants | 98 Participants | 193 Participants |
| Sex: Female, Male Male | 25 Participants | 22 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 120 | 0 / 120 |
| other Total, other adverse events | 0 / 120 | 0 / 120 |
| serious Total, serious adverse events | 0 / 120 | 0 / 120 |
Outcome results
Primary
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.
Time frame: Baseline and six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Caregiving Burden at 6 Months | -3.00 score on a scale | Standard Deviation 6.01 |
| Resources4Care (R4C) | Change From Baseline Caregiving Burden at 6 Months | -2.75 score on a scale | Standard Deviation 5.82 |
Primary
Change From Baseline Depression at 6 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.
Time frame: Baseline and six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Depression at 6 Months | -1.57 score on a scale | Standard Deviation 5.97 |
| Resources4Care (R4C) | Change From Baseline Depression at 6 Months | -0.57 score on a scale | Standard Deviation 5.43 |
Primary
Change From Baseline Social Support at 6 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.
Time frame: Baseline and six months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Social Support at 6 Months | SPS Reliable Alliance | 0.13 score on a scale | Standard Deviation 2.56 |
| GamePlan4Care (GP4C) | Change From Baseline Social Support at 6 Months | SPS Guidance | 0.42 score on a scale | Standard Deviation 1.96 |
| Resources4Care (R4C) | Change From Baseline Social Support at 6 Months | SPS Reliable Alliance | 0.01 score on a scale | Standard Deviation 2.51 |
| Resources4Care (R4C) | Change From Baseline Social Support at 6 Months | SPS Guidance | 0.46 score on a scale | Standard Deviation 2.33 |
Secondary
Change From Baseline Caregiver Stress at 6 Months
Assessment 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.
Time frame: Baseline and six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Caregiver Stress at 6 Months | -1.41 score on a scale | Standard Deviation 6.33 |
| Resources4Care (R4C) | Change From Baseline Caregiver Stress at 6 Months | -1.22 score on a scale | Standard Deviation 5.64 |
Secondary
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 : 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.
Time frame: At Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months | -2.62 score on a scale | Standard Deviation 8.83 |
| Resources4Care (R4C) | Change From Baseline Neuropsychiatric Symptoms in Care-recipient/Corresponding Caregiver Distress at 6 Months | -1.53 score on a scale | Standard Deviation 7.5 |
Secondary
Change From Baseline Reported Positive Aspects of Caregiving at 6 Months
Assessment 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.
Time frame: Baseline and six months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GamePlan4Care (GP4C) | Change From Baseline Reported Positive Aspects of Caregiving at 6 Months | 1.95 score on a scale | Standard Deviation 7.42 |
| Resources4Care (R4C) | Change From Baseline Reported Positive Aspects of Caregiving at 6 Months | 1.35 score on a scale | Standard Deviation 5.75 |