Hospital GamePlan4Care for Caregivers

Overseen By Molly Horstman, MD MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Unable to complete informed consent

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 34

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to support caregivers of Veterans with dementia who have recently been discharged from the hospital. Researchers are comparing two programs: Hospital GamePlan4Care, which offers tailored training and support, and Caregiver Education, which provides general caregiving information. The goal is to help caregivers manage the increased demands of caring for someone with dementia after a hospital stay. Caregivers of Veterans with dementia at the Michael E. DeBakey VA Medical Center who provide at least eight hours of care weekly might be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative caregiving strategies and improve support for Veterans and their families.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these support programs are safe for caregivers?

Research shows that the Hospital GamePlan4Care program aids caregivers of adults with dementia. Studies indicate it helps caregivers acquire essential skills for managing care after a hospital stay. Available online, this program uses proven training methods, providing caregivers with reliable skills and resources.

Previous studies have tested similar support programs for caregivers and found them well-received. Reports of negative effects from these types of support programs are rare. The online format of GamePlan4Care allows caregivers to learn at their own pace, offering a safe and low-risk way to gain new skills. Overall, data suggest that these caregiver support programs are safe and beneficial for those caring for someone with dementia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Hospital GamePlan4Care because it provides tailored skills training and support specifically for caregivers of people with dementia, unlike traditional caregiving education which tends to be more generalized. This personalized approach aims to equip caregivers with practical strategies that are directly applicable to the unique challenges they face. By focusing on the specific needs of dementia caregiving, this method has the potential to improve both caregiver well-being and the quality of care for those with dementia.

What evidence suggests that this trial's programs could be effective for caregivers of adults with dementia?

Research has shown that the Hospital GamePlan4Care program, available to participants in this trial, can effectively assist caregivers of people with dementia. Caregivers in similar programs have experienced significant improvements, including a noticeable decrease in caregiving stress. This program provides personalized online training, a handbook, and phone support from experts, which have proven to enhance caregivers' skills and well-being. Participants have reported positive feedback on how the program helps manage caregiving stress. Overall, the program aims to ease the transition from hospital to home by equipping caregivers with practical skills and support, which has shown a positive impact. ^{1 3 6 7 8}

Who Is on the Research Team?

Molly Horstman, MD MS

Principal Investigator

Michael E. DeBakey VA Medical Center, Houston, TX

Are You a Good Fit for This Trial?

This trial is for caregivers of Veterans with dementia admitted to the Michael E. DeBakey VA Medical Center in Houston, Texas. Caregivers must be willing to participate in a study for at least three months and complete several questionnaires.

Inclusion Criteria

Provide care primarily due to a personal relationship, rather than a financial relationship

Veteran must be experiencing signs of dementia as verified by a score of 2 or greater on the AD-8

Have access to a telephone

Exclusion Criteria

I am unable to understand or sign the consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Caregivers receive either Hospital GamePlan4Care or Caregiver Education program starting from the hospitalization of the person with dementia.

3 months

4 scheduled contacts with a Dementia Care Specialist

Follow-up

Participants are monitored for caregiver-reported outcomes such as burden, depression, and self-efficacy.

3 months

Questionnaires at baseline, 30 days, and 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Hospital GamePlan4Care

Trial Overview The study compares two support programs: Hospital GamePlan4Care, which includes tailored online training and specialist phone calls, and Caregiver Education, offering general resources and specialist support. Each lasts at least three months starting from hospitalization.

How Is the Trial Designed?

Group I: Hospital GamePlan4care Experimental Treatment 1 Intervention

Tailored caregiver skills training and support for caregiving for a person with dementia

Group II: Health Education Active Control 1 Intervention

Education on general caregiving topics.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A multidisciplinary team intervention significantly improved caregiver retention of critical discharge instructions for pediatric cancer patients, with median retention scores increasing from 63 to 89 after the intervention (p = .001).

The intervention led to notable improvements in specific areas of knowledge, such as the correct choice of on-call number (from 57% to 100%, p = .004), indicating that collaborative teaching methods can enhance understanding and potentially improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retention of discharge instructions using an interdisciplinary model for at-risk children with cancer: A quality improvement initiative. Offenbacher, R., Briggs, J., Ronca, K., et al.[2022]

A study involving 293 family caregivers of hospitalized older adults revealed that caregivers play a crucial role not only in direct patient care but also in coordinating and communicating with healthcare teams.

By actively participating in care planning and oversight, family caregivers can enhance the quality of care and improve patient outcomes during hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Caregiving During the Hospitalization of an Older Relative. Glose, S.[2021]

The study involved qualitative interviews with 40 individuals from 9 hospitals, revealing that collaboration (like standing committees) is the most effective method for engaging patients in healthcare planning, followed by blended approaches and consultation methods.

Key strategies for optimizing patient engagement include involving diverse patients, ensuring patient representation in decision-making, and linking patient engagement efforts to hospital leadership, which can enhance the integration of patient perspectives in healthcare improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Approaches to optimize patient and family engagement in hospital planning and improvement: Qualitative interviews. Anderson, NN., Baker, GR., Moody, L., et al.[2021]

The Care for the Caregiver program was established to support clinicians facing emotionally distressing events, building on earlier communication and resolution programs endorsed by the Joint Commission since 2001.

Launched in 2014 across the MedStar Health System, the program has adapted to meet the evolving needs of healthcare providers, especially during the challenges posed by the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CE: Providing Care for Caregivers During COVID-19. Morales, C., Brown, MM.[2023]

A study involving 40 participants from nine hospitals identified four key themes essential for enhancing patient and family engagement (PE) in healthcare: resources, training, organizational commitment, and staff support.

Despite the recognition of PE's benefits, hospitals often lack dedicated funding and compensation for patient/family advisors, highlighting a critical barrier to effective engagement that needs further research and improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Organizational capacity for patient and family engagement in hospital planning and improvement: interviews with patient/family advisors, managers and clinicians. Anderson, NN., Baker, GR., Moody, L., et al.[2022]

Collaboration between patients, relatives, and healthcare professionals is essential for identifying and improving patient care processes, as their experiences often differ significantly.

The study highlights the importance of experience-based co-design (EBCD) in healthcare, suggesting that involving patients in quality improvement initiatives can lead to better healthcare outcomes, despite the study's limitations due to a small participant group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in neonatal care; using experience-based co-design. Gustavsson, SM.[2022]

Family caregivers play a crucial role in supporting cancer patients but often face significant challenges and distress, highlighting the need for dedicated support services.

The article introduces a new program at the Princess Margaret Cancer Center aimed at systematically addressing the needs of family caregivers, proposing a model for psychosocial interventions that could be adopted in other healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring for the Family Caregiver: Development of a Caregiver Clinic at a Cancer Hospital as Standard of Care. Nissim, RS., Hales, S.[2023]

Patient engagement (PE) in hospital planning has been shown to have 14 beneficial impacts, including improvements in hospital structures, clinician functions, patient experiences, and overall patient outcomes, based on interviews with 38 participants from 9 hospitals.

While PE activities generally have positive effects, some challenges were noted, such as the potential for overextending patient/family advisors and causing frustration among clinicians if the engagement process slowed down improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impacts of patient and family engagement in hospital planning and improvement: qualitative interviews with patient/family advisors and hospital staff. Anderson, NN., Dong, K., Baker, GR., et al.[2022]

As cancer care shifts from hospitals to home settings, family members often take on the primary caregiving role for patients, highlighting the need for support systems.

Research has identified the specific family members who typically provide care, their needs, and the gaps in community resources and healthcare services available to assist them.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Needs of family caregivers of persons with cancer: a review. Laizner, AM., Yost, LM., Barg, FK., et al.[2019]

A study involving 506 family caregivers of hospitalized patients aged 70 and older found that collaboration with hospital nurses significantly improves caregivers' preparedness for their caregiving tasks after discharge.

The research highlights the importance of involving family caregivers as partners in care, suggesting that better communication and collaboration with nurses can enhance the quality of care for older patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of collaboration between family caregivers and nurses in the hospital and their preparedness for caregiving at home. Hagedoorn, EI., Keers, JC., Jaarsma, T., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12519501/

A randomized trial of two online platforms for dementia family ... Caregivers showed significant follow‐up improvements in burden (GP4C: effect size [ES] = 0.50, p < 0.001; R4C: ES = 0.47, p < 0.001), positive ...

2. clinicaltrials.gov clinicaltrials.gov/show/NCT04540198

GamePlan4Care: Online Support for Family Caregivers Assessment of favorable aspects of caregiving experiences: The PAC was measured with 11 items of the favorable aspects of caregiving experience. Each question ...

3. formative.jmir.org formative.jmir.org/2025/1/e60143

GamePlan4Care, a Web-Based Adaptation of the Resources ... The goal of GP4C is to create a web-based family caregiver support platform that facilitates self-directed exposure to evidence-based skills training and ...

4. sciencedirect.com sciencedirect.com/org/science/article/pii/S2561326X2500469X

GamePlan4Care, a Web-Based Adaptation of the ... Usability testing and participants' in-depth and positive feedback showed its functionality and utility as a potential caregiver support program for dementia ...

5. hsrd.research.va.gov hsrd.research.va.gov/research/citations/abstract.cfm?Identifier=163551

HSR Citation Abstract - VA Health Systems Research RESULTS: Two distinct caregiving intensity patterns, high-intensity (37.5%) and low-intensity (62.5%) caregiving, were identified with cluster analysis.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06634368

NCT06634368 | Pilot Study of Hospital GamePlan4Care Caregivers randomized to Caregiver Education will receive: 1) four automated emails after hospital discharge with recommended resources from the Home Alone ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41085219/

A randomized trial of two online platforms for dementia ... Caregivers engaged more in GP4C (GP4C: mean 5.5 h, SD = 0.61; R4C: mean 1.9 h, SD = 0.20) and set more goals for the safety domain (mean 8.9 goals, SD = 7.60).

8. hsrd.research.va.gov hsrd.research.va.gov/research/abstracts.cfm?Project_ID=2141709132

CDA 21-143 – HSR Study - VA Health Systems Research GamePlan4Care (GP4C) is a novel, web-based training platform designed to fully replicate the core components of REACH II in an acceptable and scalable online ...