| NCT ID | NCT06634368 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Caregivers |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-04 |
| Primary Completion | 2026-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-02-04 with a primary completion date of 2026-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 18 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 Exclusion Criteria: * unable to complete informed consent
Contact & Investigator
Molly Horstman, MD MS
PRINCIPAL INVESTIGATOR
Michael E. DeBakey VA Medical Center, Houston, TX
Frequently Asked Questions
Who can join the NCT06634368 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Caregivers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06634368 currently recruiting?
Yes, NCT06634368 is actively recruiting participants. Contact the research team at molly.horstman1@va.gov for enrollment information.
Where is the NCT06634368 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06634368 clinical trial?
NCT06634368 is sponsored by VA Office of Research and Development. The principal investigator is Molly Horstman, MD MS at Michael E. DeBakey VA Medical Center, Houston, TX. The trial plans to enroll 50 participants.