CaregiversNCT07387614
WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME
A study testing Hospital GamePlan4Care and Health Education in people with Caregivers, run by Baylor College of Medicine at 1 site in United States.
Trial 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. 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
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Show all 10Show fewer
- 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. Contact the study team or a site near you to ask about taking part.
United States1 site
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Caregivers
- Being tested
- Hospital GamePlan4Care, Health Education
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.
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.
Measured: Baseline, 30 days and 90 days
Secondary outcomes (6)
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 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 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 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 Caregiver Distress on the 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) and the level of distress the caregiver feels due to that symptom (0-5). Higher scores indicate greater distress due to that symptom.
Measured: Baseline, 30 days, and 90 days
Neglect and Aggression Questionnaire
Questions adapted from the Conflict Tactics Scale Revised and CTS2 modified for older adults; Conflict Tactics Scale for Child Mistreatment; and prior research (Pickering 2024, PMID 39136354). Asks how often the caregiver or care recipient has done I something in the past month. Questions include neglect of the care recipient, caregiver self-neglect, physical and psychological aggression of the caregiver to the care recipient, and physical and psychological aggression of the care recipient to the caregiver.
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 posted4 Feb 2026
- Study start1 Jun 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
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 Baylor College of MedicineThe 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 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), The University of Texas Health Science Center, Houston
- Responsible party
- Principal investigator, Molly Horstman, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07387614
- Sponsor's protocol ID
- H-55864
- Other IDs
- 5P30AG086563-02
- Status last verified
- Jun 2026
- First submitted
- 28 Jan 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEB-BASED SUPPORT PROGRAM FOR CAREGIVERS OF VETERANS WITH DEMENTIA DISCHARGED FROM SKILLED NURSING FACILITIES TO HOME
- ClinicalTrials.gov ID
- NCT07387614
- Acronym / sponsor ID
- H-55864
- Conditions
- Caregivers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), The University of Texas Health Science Center, Houston
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 4 Feb 2026 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| 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 (10 listed)
- 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
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
Caregiver Unmet Needs: Benjamin Rose Unmet Needs Scale
Time frame: Baseline, 30 days and 90 days
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Baylor College of Medicine 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 10 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: enrolling by invitation, as of the sponsor's last update on 29 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Caregiver Unmet Needs: Benjamin Rose Unmet Needs Scale (time frame: Baseline, 30 days and 90 days). 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 29 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.