NCT07387614

Brief Summary

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:

  • Is Hospital GamePlan4Care feasible and acceptable to caregivers?
  • Does Hospital GamePlan4Care improve caregiver-reported outcomes? 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:
  • Complete tailored skills training on the Hospital GamePlan4Care website
  • Complete four phone calls with a dementia care specialist to receive tailored training and support
  • Complete questionnaires at enrollment, one month, and three months after enrollment.
  • Complete an interview at three months Participants in the health education arm will receive education materials for caregivers. Participants will be asked to:
  • Review the education materials
  • Complete four phone calls with a dementia care specialist to review the materials
  • Complete questionnaires at enrollment, one month, and three months after enrollment.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Feb 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress22%
Feb 2026Feb 2027

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 17, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2027

Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Change in Self-Efficacy for Caregiving (CSES-8)

    Baseline, 30 days, and 90 days

  • Change in Center for Epidemiological Studies Depression Scale (CES-D) (10-item)

    Baseline, 30 days, and 90 days

  • Change in Zarit Caregiving Burden Interview (12-item)

    Baseline, 30 days and 90 days

  • Change in Self-Rated Health (1-item)

    Baseline, 30 days, and 90 days

  • Change in Caregiver Distress on the Neuropsychiatric Inventory Questionnaire

    Baseline, 30 days, and 90 days

  • +1 more secondary outcomes

Study Arms (2)

Hospital GamePlan4Care

EXPERIMENTAL

Tailored caregiver skills training and support for caregiving for a person with dementia

Behavioral: Hospital GamePlan4Care

Health Education

ACTIVE COMPARATOR

Education on general caregiving topics.

Other: Health Education

Interventions

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.

Health Education

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

Hospital GamePlan4Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • care for a Veteran with dementia who is discharged to a VA or non-VA skilled nursing facility prior to returning home
  • 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, Texas, 77030, United States

Location

Central Study Contacts

Molly Horstman, MD, MS

CONTACT

Timothy Zhou, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

February 17, 2026

Primary Completion (Estimated)

February 17, 2027

Study Completion (Estimated)

February 17, 2027

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

The investigators will provide a de-identified dataset compliant with VA data security policy to the public upon request to the principal investigator.

Time Frame
After the data is analyzed and published

Locations