Pilot Study of Hospital GamePlan4Care
ConditionCaregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
unable to complete informed consent
Trial design
Design model
Parallel
Treatments tested in this trial
Hospital GamePlan4Care
BehavioralThe 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.
Health Education
Other interventionCaregivers 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Hospital GamePlan4careExperimental treatment 1 intervention
Group B: Health EducationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline, 30 days and 90 days2
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).
Time frame
Baseline, 30 days, and 90 days3
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
Time frame
Baseline, 30 days, and 90 days4
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.
Time frame
Baseline, 30 days, and 90 daysSecondary outcomes
1
Change in Self-Efficacy for Caregiving (CSES-8)
The CSES-8 asks questions about confidence in being able to manage different caregiving situations. Each question is rated on a 1 (not at all confident) to 10 (totally confident scale). The score of the scale is the mean of the eight items. Higher scores indicate greater self-efficacy.
Time frame
Baseline, 30 days, and 90 days2
Change in Benjamin Rose Institute Unmet Need 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.
Time frame
Baseline, 30 days, and 90 daysOther outcomes
1
Change in VA Unplanned Acute Care Use
Measure VA and VA-paid emergency room visits and unplanned readmissions.
Time frame
30 days and 90 days2
Change in VA Home and Community-Based Services
Measure VA and VA-paid Home and Community-Based Services, including home-based primary care, home skilled care, homemaker/home health aide, adult day health care, home hospice care, and respite care
Time frame
30 days and 90 daysSponsors and contacts
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Source ClinicalTrials.gov