Clinical trial NCT06634368: Pilot Study of Hospital GamePlan4Care
Official title: Pilot Study of Hospital GamePlan4Care for Family Caregivers of People With Dementia (CDA 21-143)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregivers
Keywords: Dementia
Hospitalization
Patient Discharge
Caregiver Burden
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-10-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-blind, parallel group, randomized pilot trial of a 3-month caregiver support intervention for caregivers of hospitalized Veterans with dementia compared to health education. Participants will be assigned at random to the intervention (Hospital GamePlan4Care) or health education control. Assessment of the primary and secondary outcomes will occur pre-intervention at baseline and post-intervention at 1 and 3 months.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The efficacy of support interventions designed for caregivers of adults with dementia and delivered as part of hospital care has not been established. Hospital GamePlan4Care is a new intervention that has been developed and tested with feedback from caregivers and health professionals. Hospital GamePlan4Care was feasible to implement during hospital care and acceptable to caregivers in a single-arm feasibility and acceptability pilot. There are no prior caregiver support interventions that include the same population (caregivers of adults with dementia), intervention delivery mechanism (web-based intervention), and practice setting (intervention started in the hospital and continued following discharge) to estimate effect sizes for a large randomized control trial of Hospital GamePlan4Care.This study will be a pilot single-blind randomized study comparing Hospital GamePlan4Care (intervention arm) to a Health Education Control arm (Caregiver Education). Caregivers will be assigned to the intervention or control arm in a ratio of 1:1. Each arm will continue for three months after the Veteran is discharged from the hospital.

Caregivers of adults with dementia will be recruited while the Veteran they care for is hospitalized. The research coordinator will complete the informed consent with the caregiver before the Veteran is discharged. All enrolled caregivers will receive a VA Care Transitions handbook. 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. All Veterans and caregivers will receive standard hospital discharge planning and post-discharge care. A standard hospital discharge includes a consultation with an inpatient social worker or case manager, inpatient medication reconciliation, patient-centered written discharge instructions, a post-discharge phone call from the Veteran's primary care clinic, and scheduled follow-up appointments. The primary outcomes are caregiver-reported and will be measured 30 days and 90 days after hospital discharge.

Caregivers randomized to Hospital GamePlan4Care will receive 1) access to the Hospital GamePlan4Care website that includes training content relevant to caregivers during care transitions, such as learning how to complete new medical tasks, managing delirium, and addressing dementia behaviors, 2) 11 automated emails after hospital discharge that highlight Hospital GamePlan4Care training content and encourage caregivers to log into the website, and 3) four scheduled contacts with a Dementia Care Specialist after hospital discharge to tailor the intervention to the caregivers needs. Scheduled contacts with the Dementia Care Specialist will be on Day 2, Day 14, Day 28, and Day 60 after discharge.

Caregivers randomized to Caregiver Education will receive: 1) four automated emails after hospital discharge with recommended resources from the Home Alone Alliance, which provides high-quality training videos for caregivers, and 2) four scheduled phone calls with the Dementia Care Specialist after hospital discharge to confirm the emails were received and to see if the caregiver has any questions about the materials. Emails will be sent on Day 2, Day 14, Day 28, and Day 60 after discharge, and phone calls will be made after each email is sent.

The results from this study will inform the feasibility and sample size calculation for a multisite randomized controlled trial to test the efficacy of Hospital GP4C to improve caregiver-reported outcomes.

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

Primary outcomes:
measure: Change in Zarit Caregiving Burden Interview (12-item)
timeFrame: Baseline, 30 days and 90 days
measure: Change in Center for Epidemiological Studies Depression Scale (CES-D) (10-item)
timeFrame: Baseline, 30 days, and 90 days
measure: Change in Self-Rated Health (1-item)
timeFrame: Baseline, 30 days, and 90 days
measure: Change in Neuropsychiatric Inventory Questionnaire
timeFrame: Baseline, 30 days, and 90 days
Secondary outcomes:
measure: Change in Self-Efficacy for Caregiving (CSES-8)
timeFrame: Baseline, 30 days, and 90 days
measure: Change in Benjamin Rose Institute Unmet Need Scale
timeFrame: Baseline, 30 days, and 90 days
Other outcomes:
measure: Change in VA Unplanned Acute Care Use
timeFrame: 30 days and 90 days
measure: Change in VA Home and Community-Based Services
timeFrame: 30 days and 90 days
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Molly Horstman, MD MS
role: PRINCIPAL_INVESTIGATOR
References: