Pilot Study of Hospital GamePlan4Care
1 other identifier
interventional
50
1 country
1
Brief Summary
Hospital stays are stressful for the family and friends who care for adults with dementia. Following hospital discharge, adults with dementia often have increased care needs, which places new caregiving demands on their family and friends. Family and friends are critical to ensuring that Veterans with dementia can live safely in the community following discharge. Healthcare systems have an opportunity to support family and friends of adults with dementia by addressing dementia-specific caregiving challenges that arise during the transition from hospital to home. The investigators are comparing two different support programs for family and friends of hospitalized adults with dementia. The two programs are Hospital GamePlan4Care and Caregiver Education. Hospital GamePlan4Care was developed with feedback from people who care for Veterans with dementia. Hospital GamePlan4Care helps caregivers build skills to care for someone with dementia recently discharged from the hospital. It includes a written handbook, online training on the Hospital GamePlan4Care website, and phone calls with a dementia care specialist. The online training is tailored to the caregiver. The Caregiver Education program provides information that helps caregivers care for someone recently hospitalized. It includes a written handbook, recommendations for high-quality online resources, and phone calls with a dementia care specialist. Both programs will start when the adult with dementia is hospitalized. Each program lasts at least three months. To be eligible, the caregiver must care for a Veteran with dementia admitted to the Michael E. DeBakey VA Medical Center in Houston, Texas. Caregivers interested in participating and passing eligibility screening will be enrolled in the study for at least three months. Each enrolled caregiver will have a 50% chance of being enrolled in the Hospital GamePlan4Care group or the Caregiver Education group (like flipping a coin). Both groups will be asked to complete several questionnaires about their needs as a caregiver and their well-being. Questionnaires will be completed at the beginning of the study and one and three months after the Veteran is discharged from the hospital. Each questionnaire should take 30-60 minutes to complete.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2024
CompletedFirst Posted
Study publicly available on registry
October 9, 2024
CompletedStudy Start
First participant enrolled
February 4, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
January 8, 2026
January 1, 2026
1.3 years
October 7, 2024
January 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 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 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 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), the severity of the symptom if present (1-3), and the level of distress the caregiver feels due to that symptom (0-5). Higher scores indicate higher severity and greater distress due to that symptom.
Baseline, 30 days, and 90 days
Secondary Outcomes (2)
Change in Self-Efficacy for Caregiving (CSES-8)
Baseline, 30 days, and 90 days
Change in Benjamin Rose Institute Unmet Need Scale
Baseline, 30 days, and 90 days
Other Outcomes (2)
Change in VA Unplanned Acute Care Use
30 days and 90 days
Change in VA Home and Community-Based Services
30 days and 90 days
Study Arms (2)
Hospital GamePlan4care
EXPERIMENTALTailored caregiver skills training and support for caregiving for a person with dementia
Health Education
ACTIVE COMPARATOREducation on general caregiving topics.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- years of age or older
- provide care for a Veteran with a diagnosis of Alzheimer's Disease or related dementias or a Veteran with a prescription for a medication for dementia listed in CPRS who is admitted to the hospital at the Michael E. DeBakey VA Medical Center
- Veteran must be experiencing signs of dementia as verified by a score of 2 or greater on the AD-8
- provide at least eight hours of care or supervision per week to the Veteran with dementia
- provide care primarily due to a personal relationship, rather than a financial relationship
- have access to a telephone
- have access to a tablet or computer with internet access
- report using the computer or tablet to access the internet at least three times per week
- speak English
You may not qualify if:
- unable to complete informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Molly Horstman, MD MS
Michael E. DeBakey VA Medical Center, Houston, TX
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2024
First Posted
October 9, 2024
Study Start
February 4, 2025
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
May 30, 2026
Last Updated
January 8, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- After the data is analyzed and published
The investigators will provide a de-identified dataset compliant with VA data security policy to the public upon request to the principal investigator.