CaregiversNCT06634368
Pilot Study of Hospital GamePlan4Care
A study testing Hospital GamePlan4Care and Health Education in people with Caregivers, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Caregivers
- What is being tested?
- Hospital GamePlan4Care and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2025to 14 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to complete informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, 77030-4211
About this study
Official title: Pilot Study of Hospital GamePlan4Care for Family Caregivers of People With Dementia (CDA 21-143)
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.
Read the 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.
- Conditions
- Caregivers
- Being tested
- Hospital GamePlan4Care, Health Education
- Keywords
- Dementia, Hospitalization, Patient Discharge, Caregiver Burden
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital GamePlan4CareBehavioural
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.
Health EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Hospital GamePlan4care | Experimental | Tailored caregiver skills training and support for caregiving for a person with dementia Receives: Behavioral: Hospital GamePlan4Care |
| Health Education | Active comparator | Education on general caregiving topics. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 30 days and 90 days
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).
Measured: Baseline, 30 days, and 90 days
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
Measured: Baseline, 30 days, and 90 days
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.
Measured: Baseline, 30 days, and 90 days
Secondary outcomes (2)
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.
Measured: Baseline, 30 days, and 90 days
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.
Measured: Baseline, 30 days, and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start4 Feb 2025
- Primary completion14 Sep 2026
- Study completion14 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaregiversStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Molly Horstman, MD MS, Principal investigator, Michael E. DeBakey VA Medical Center, Houston, TX
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06634368
- Sponsor's protocol ID
- CDX 24-003
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2024
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will provide a de-identified dataset compliant with VA data security policy to the public upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Hospital GamePlan4Care for Family Caregivers of People With Dementia (CDA 21-143)
- ClinicalTrials.gov ID
- NCT06634368
- Acronym / sponsor ID
- CDX 24-003
- Conditions
- Caregivers
- Keywords
- Dementia, Hospitalization, Patient Discharge, Caregiver Burden
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 14 Sep 2026 (actual)
- Study completion
- 14 Sep 2026 (actual)
- First posted
- 9 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Hospital GamePlan4care | Experimental | Behavioral: Hospital GamePlan4CareTailored caregiver skills training and support for caregiving for a person with dementia |
| Health Education | Active comparator | Other: Health EducationEducation on general caregiving topics. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- unable to complete informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hospital GamePlan4CareThe 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. | Behavioural | Hospital GamePlan4care |
| Health EducationCaregivers 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. | Other | Health Education |
Primary outcome
Change in Zarit Caregiving Burden Interview (12-item)
Time frame: Baseline, 30 days and 90 days
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).
Change in Center for Epidemiological Studies Depression Scale (CES-D) (10-item)
Time frame: Baseline, 30 days, and 90 days
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).
Change in Self-Rated Health (1-item)
Time frame: Baseline, 30 days, and 90 days
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
Change in Neuropsychiatric Inventory Questionnaire
Time frame: Baseline, 30 days, and 90 days
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.
2 secondary outcomes
Change in Self-Efficacy for Caregiving (CSES-8)
Time frame: Baseline, 30 days, and 90 days
Change in Benjamin Rose Institute Unmet Need Scale
Time frame: Baseline, 30 days, and 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Yes. The investigators will provide a de-identified dataset compliant with VA data security policy to the public upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Molly Horstman, MD MS principal investigator
Michael E. DeBakey VA Medical Center, Houston, TX
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital GamePlan4Care and Health Education in people with Caregivers, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Zarit Caregiving Burden Interview (12-item) (time frame: Baseline, 30 days and 90 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.