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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30AG086563-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| The University of Texas Health Science Center, Houston | OTHER |
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The goal of this clinical trial is to learn whether an evidence-based caregiver support program (Hospital GamePlan4Care) can benefit caregivers of hospitalized Veterans with Alzheimer's Disease and Related Dementia who are discharged to skilled nursing facilities prior to returning home. The main questions it aims to answer are:
Researchers will compare Hospital GamePlan4Care to health education to see if it improves caregiver reported outcomes.
Participants in the Hospital GamePlan4Care arm will receive tailored skills training and support. Participants will be asked to:
Participants in the health education arm will receive education materials for caregivers. Participants will be asked to:
Hospital GamePlan4Care is an evidence-informed intervention designed to support caregivers of hospitalized adults with dementia. Hospital GamePlan4Care was developed and tested with feedback from caregivers and health professionals and found to be feasible and acceptable to caregivers in a single arm pilot study. Hospitalization of an adult with dementia can be associated with negative outcomes for the adult with dementia (e.g., cognitive decline, functional decline) and caregivers (e.g., depression, increased stress), which may place the adult with dementia at increased risk for elder mistreatment following hospital discharge. Supporting caregivers during care transitions may improve outcomes for caregivers and mediate the risk for elder mistreatment. This clinical trial addresses an important gap in our understanding of the potential benefits of caregiver-support programs during care transitions for caregivers and adults with dementia.
This study will be a non-blinded randomized study comparing Hospital GamePlan4Care (intervention arm) to a Health Education (control arm) for caregivers of hospitalized Veterans with dementia who are discharged to a skilled nursing facility prior to returning home. Caregivers of adults with dementia will be recruited while the Veteran is admitted to a skilled nursing facility after hospital discharge. Following baseline data collection, enrolled caregivers will be randomized to Hospital GamePlan4Care or Caregiver Education arm in a 1:1 ratio using the randomization feature in VA REDCap. Each arm will continue for three months after the caregiver is enrolled. The primary outcomes are caregiver-reported and will be measured 30 days and 90 days after caregiver enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospital GamePlan4Care | Experimental | Tailored caregiver skills training and support for caregiving for a person with dementia |
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| Health Education | Active Comparator | Education on general caregiving topics. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hospital GamePlan4Care | Behavioral | The Hospital GamePlan4Care intervention will include access to a written VA Care Transitions handbook, access to the GamePlan4Care website for skills training, 11 emails encouraging them to visit the website, and four phone calls with a dementia care specialist to tailor the training to the caregiver's needs over a 3-month period |
| Measure | Description | Time Frame |
|---|---|---|
| Caregiver Unmet Needs: Benjamin Rose Unmet Needs Scale | The Benjamin Rose Institute Unmet Need Scale includes 39 yes/no questions about different need that caregivers have (no=0, yes=1). The total score is a sum of all the yes responses. Higher scores indicate higher unmet needs. | Baseline, 30 days and 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Efficacy for Caregiving (CSES-8) | The CSES-8 asks questions about confidence in being able to manage different caregiving situations. Each question is rated on a 1 (not at all confident) to 10 (totally confident scale). The score of the scale is the mean of the eight items. Higher scores indicate greater self-efficacy. | Baseline, 30 days, and 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
The investigators will provide a de-identified dataset compliant with VA data security policy to the public upon request to the principal investigator.
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After the data is analyzed and published
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This is an unblinded, parallel group, randomized trial of a 3-month caregiver support intervention (Hospital GamePlan4Care) for caregivers of hospitalized Veterans with dementia discharged to skilled nursing facilities compared to health education.
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| Health Education | Other | Caregivers in the health education arm will receive a VA Care Transitions Handbook, 4 emails with a weblink to a general caregiving topic, and 4 phone calls to confirm that the emails were received over a 3-month period. |
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| Change in Center for Epidemiological Studies Depression Scale (CES-D) (10-item) | The CES-D provides a list of feelings and behaviors. For each item, respondents report how often they have felt that way in the past week with each item receiving a score from 0-3. A total score will be obtained by summing scores for all items with higher scores indicating higher levels of depressed symptoms (range: 0-30). | Baseline, 30 days, and 90 days |
| Change in Zarit Caregiving Burden Interview (12-item) | Each item represents a statement related to an aspect of perceived burden. All questions are answered as never (0 points), rarely (1 point), sometimes (2 points), quite frequently (3 points), or nearly always (4 points). A total score will be obtained by summing all items with higher scores indicating higher rates of burden (range: 0-48). | Baseline, 30 days and 90 days |
| Change in Self-Rated Health (1-item) | The investigators will use the single self-rated health item: "In general, would you say your health is:" with response options of Excellent, Very Good, Good, Fair, and Poor | Baseline, 30 days, and 90 days |
| Change in Caregiver Distress on the Neuropsychiatric Inventory Questionnaire | The Neuropsychiatric Inventory Questionnaire includes a list of 12 symptoms (e.g. delusions, hallucinations, agitation/aggression). For each symptom, the caregiver responds if the symptom was present in the past month (yes/no) and the level of distress the caregiver feels due to that symptom (0-5). Higher scores indicate greater distress due to that symptom. | Baseline, 30 days, and 90 days |
| Neglect and Aggression Questionnaire | Questions adapted from the Conflict Tactics Scale Revised and CTS2 modified for older adults; Conflict Tactics Scale for Child Mistreatment; and prior research (Pickering 2024, PMID 39136354). Asks how often the caregiver or care recipient has done I something in the past month. Questions include neglect of the care recipient, caregiver self-neglect, physical and psychological aggression of the caregiver to the care recipient, and physical and psychological aggression of the care recipient to the caregiver. | Baseline, 30 days, and 90 days |