WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME

Overview

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.

Detailed description

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.

Interventions

• Behavioral Hospital GamePlan4Care
  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
• Other Health Education
  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.

Primary outcome measures

• Caregiver Unmet Needs: Benjamin Rose Unmet Needs Scale [Time frame: Baseline, 30 days and 90 days]

Secondary outcome measures (6)

• Change in Self-Efficacy for Caregiving (CSES-8) [Time frame: Baseline, 30 days, and 90 days]
• Change in Center for Epidemiological Studies Depression Scale (CES-D) (10-item) [Time frame: Baseline, 30 days, and 90 days]
• Change in Zarit Caregiving Burden Interview (12-item) [Time frame: Baseline, 30 days and 90 days]
• Change in Self-Rated Health (1-item) [Time frame: Baseline, 30 days, and 90 days]
• Change in Caregiver Distress on the Neuropsychiatric Inventory Questionnaire [Time frame: Baseline, 30 days, and 90 days]
• Neglect and Aggression Questionnaire [Time frame: Baseline, 30 days, and 90 days]

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
• 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

Exclusion criteria

• unable to complete informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Michael E. DeBakey VA Medical Center — Houston

Identifiers

NCT: NCT07387614 · H-55864 · 5P30AG086563-02

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗