Virtual Health Coach for Caregiver Stress

(iCare4Me T Trial)

Recruiting at 2 trial locations

Overseen By Aderike Adesanya, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Pennsylvania

Disqualifiers: Cognitive deficits, Untreated psychiatric illness, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 11

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to help caregivers of older adults improve their self-care: virtual health coaching (Virtual Health Coach for You) and web-based information. Researchers aim to determine which method is more effective for caregivers assisting hospital patients with multiple chronic conditions transitioning back home. The trial also examines outcomes based on the caregiver's background and investigates the cost and use of healthcare resources. It suits caregivers who provide at least 8 hours of care per week, feel they struggle with self-care, and are comfortable using technology. Participants will be randomly assigned to one of two groups and will engage in interviews and follow-ups over six months. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking caregiving solution.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, it mentions that using anti-anxiety or anti-depressant medicines is acceptable.

Is there any evidence suggesting that this trial's interventions are likely to be safe?

Research has shown that virtual health coaching is safe and easy for caregivers to manage. In a previous study, caregivers who received this coaching felt less stressed and took better care of themselves, indicating that the coaching was manageable and harmless. No reports of negative effects from the coaching itself have emerged. Additionally, since this trial is in a later stage, evidence already suggests that the approach is generally safe for participants. This should reassure those considering joining that the treatment is likely safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Virtual Health Coach for caregiver stress because it offers a personalized and interactive approach to managing stress, which is different from traditional methods like in-person therapy or support groups. This treatment combines digital health information with virtual coaching sessions, providing caregivers with tailored guidance and support over a six-month period. The virtual format allows for flexibility and convenience, enabling caregivers to access resources and coaching from the comfort of their homes. By integrating technology with personalized coaching, this approach has the potential to enhance caregiver well-being in a way that standard methods might not fully achieve.

What evidence suggests that this trial's interventions could be effective for caregiver stress?

Research has shown that virtual health coaching can help caregivers take better care of themselves. In past studies, health coaching lowered stress for caregivers and improved their overall well-being. For example, while not all methods succeeded, some effectively reduced the challenges caregivers face and enhanced their quality of life. One study found that when caregivers experienced less stress, the health of those they care for also improved. In this trial, participants in the "Virtual Health Coaching + DHI" arm will receive a 10-session virtual health coaching intervention over 6 months. This aims to help caregivers manage their duties more effectively, potentially leading to better outcomes for both them and their loved ones. ^{1 2 6 7 8}

Who Is on the Research Team?

Karen Hirschman, Ph.D.

Principal Investigator

University of Pennsylvia

Are You a Good Fit for This Trial?

This trial is for caregivers aged 18+ who provide at least 8 hours of weekly care to hospitalized adults over 65, have poor self-care habits, are willing and able to use technology, and speak English. Those with cognitive deficits, enrolled in similar trials, or with untreated major psychiatric illnesses cannot participate.

Inclusion Criteria

Willing to use technology (e.g., computer, smartphone, iPad/tablet)

Able to complete the protocol, e.g., adequate vision and hearing

English speaking

Exclusion Criteria

I have no untreated major mental health conditions.

Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)

Participation in another similar support or care transition trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomly assigned to either the digital health information group or the virtual health coaching plus digital health information group for six months

6 months

10 virtual health coaching sessions for the intervention group

Follow-up

Participants are monitored for outcomes such as self-care, caregiver self-efficacy, coping, stress, and health status

6 months

Baseline interview, check-in call at 1 month, follow-up interviews at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Health Coach for You

Trial Overview The study compares a virtual health coach intervention against web-based health information alone for improving self-care among caregivers of older adults transitioning from hospital to home. It will also assess the interventions' cost-effectiveness and impact on caregiver stress and confidence.

How Is the Trial Designed?

Group I: Virtual Health Coaching + DHI Experimental Treatment 2 Interventions

Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.

Group II: Digital Health Information (DHI) Active Control 1 Intervention

Digital health information is delivered through a website tailored with care transitions and self-care information for all participants over the 6-month study.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The Interprofessional Virtual Healthcare Neighborhood (VHN) provided support and resources to caregivers of individuals with dementia, but it did not significantly improve sleep quality or quantity for participants, as measured by actigraphy.

While insomnia severity decreased for both the VHN and usual care groups, self-efficacy remained stable for the VHN group, contrasting with a decline in the comparison group, highlighting the potential benefits of the VHN in maintaining caregiver confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interprofessional Virtual Healthcare Neighborhood: Effect on Self-Efficacy and Sleep Among Caregivers of Older Adults With Dementia. Fowler, CN., Kott, K., Wicks, MN., et al.[2018]

A systematic review of 65 studies on telehealth interventions for family caregivers found that over 95% reported significant improvements in caregiver outcomes, indicating high efficacy of these interventions.

Caregivers expressed satisfaction and comfort with telehealth technologies, which included various methods like video and telephone, suggesting that telehealth can effectively support chronic disease management and home care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of telehealth tools and interventions to support family caregivers. Chi, NC., Demiris, G.[2018]

This case report highlights the successful use of health and wellness coaching (HWC) for a 44-year-old woman caring for a cancer patient, showing potential benefits in managing her physical health issues like hypertension and high cholesterol over a 1-year period.

The intervention, consisting of 10 sessions, addressed various health components and demonstrated that HWC can lead to positive physical and psychosocial outcomes for cancer caregivers, suggesting it as a valuable support option for this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Health and Wellness Coaching With an Adult Cancer Caregiver. Smith, K., Hays, L., Yen, L., et al.[2022]

A systematic review of 24 trials (8 open-label and 16 randomized) found that internet-based interventions can effectively reduce caregiver stress, with 6 out of 16 randomized trials showing positive benefits.

While many interventions were effective, there was no consistent pattern in study variables that predicted better outcomes, indicating a need for further research to optimize these interventions for caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. Hu, C., Kung, S., Rummans, TA., et al.[2022]

Home-based caregivers of individuals with dementia experience significant stress primarily due to challenges in medication management, memory loss, hygiene care, and disruptive behaviors, highlighting the need for targeted support.

Professional caregivers have better access to resources and technology, which could be beneficial if adapted for home-based caregivers, but any new technology must be designed with a focus on the human experience to effectively support both caregivers and those with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress in the Volunteer Caregiver: Human-Centric Technology Can Support Both Caregivers and People with Dementia. Huelat, B., Pochron, ST.[2021]

A pilot study involving 64 family caregivers of frail older adults showed that an 8-week social media-based mind-body intervention, which included mindfulness meditation and self-administered acupressure, significantly reduced caregiver stress and improved sleep quality and mindfulness awareness compared to a control group.

The intervention demonstrated high feasibility with an 87.5% attendance rate and low attrition (1.6%), indicating that it is a practical and engaging option for caregivers, although it did not significantly reduce caregiver burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Social Media-Based Mind-Body Intervention Embedded With Acupressure and Mindfulness for Stress Reduction Among Family Caregivers of Frail Older Adults: Pilot Randomized Controlled Trial. Sui, Y., Kor, PPK., Li, M., et al.[2023]

The 'Partner in Balance' (PiB) program, which combines face-to-face coaching with online modules, was well-received by both caregivers and coaches, with a participation rate of 51.9% among eligible caregivers, indicating its potential effectiveness in supporting early-stage dementia caregivers.

Despite overall satisfaction, challenges such as recruitment barriers and the need for tailored content for specific subgroups, like younger caregivers, were identified, suggesting that further adaptation and awareness of blended care programs are necessary for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of the Blended Care Self-Management Program for Caregivers of People With Early-Stage Dementia (Partner in Balance): Process Evaluation of a Randomized Controlled Trial. Boots, LM., de Vugt, ME., Smeets, CM., et al.[2022]

The iCare Stress Management e-Training Program significantly reduced perceived stress among dementia family caregivers compared to an Education/Information-Only condition, indicating its potential efficacy in stress management.

Despite the positive results, the study faced a high dropout rate of about one-third of participants, highlighting the need for strategies to enhance engagement and retention in future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. Kajiyama, B., Thompson, LW., Eto-Iwase, T., et al.[2022]

A pilot study showed that a Virtual Mindfulness Coach is more effective than self-administered training in helping students establish a regular mindfulness practice, indicating its potential for enhancing patient education and behavior change.

Participants using the virtual coach reported higher self-efficacy and were in more advanced stages of change according to the transtheoretical model, suggesting that the interactive and adaptive features of the coach contribute significantly to its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual training and coaching of health behavior: example from mindfulness meditation training. Hudlicka, E.[2022]

A pilot study involving 23 family caregivers showed that an internet-based psychological intervention significantly reduced care-associated stress, anxiety, and depressive symptoms after treatment.

Participants also experienced a notable increase in self-efficacy, suggesting that this online intervention is effective in helping caregivers manage their psychological stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[An internet-based intervention for health promotion in family caregivers--results of a pilot study]. Böttche, M., Klasen, M., Knaevelsrud, C.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220798

NCT07220798 | Virtual Caregiver Coach for You (ViCCY) Stress, Psychological. Behavioral Symptoms. Behavior. Heart Failure. Cognitive Dysfunction. Caregiver Burden. Plan for Individual Participant ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6815729/

Health Coaching to Improve Self-Care of Informal Caregivers ... An exploratory aim is to examine the effect of caregiver outcomes on HF patient outcomes, as caregiver burden and stress are associated with higher rates of ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.123.011475

Health Coaching Improves Outcomes of Informal ... A systematic review of interventions for HF caregivers showed limited effectiveness. With only half impacting caregiver burden and well-being, ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.067445

Effectiveness of a virtual health coach intervention for ... A tremendous burden is placed on caregivers who often sacrifice ... outcomes in this distressed and underserved caregiver population.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714419305609

Health coaching to improve self-care of informal caregivers ... An exploratory aim is to examine the effect of caregiver outcomes on HF patient outcomes, as caregiver burden and stress are associated with higher rates of ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.12381

iCare4Me for FTD: A pilot randomized study to improve self ... This study showed caregiver improvements in affect, stress, and burden in the intervention group compared to an attention control group.

7. thecardiologyadvisor.com thecardiologyadvisor.com/news/health-coaching-intervention-improves-self-care-and-stress-in-caregivers-of-hf-patients/

Health Coaching Intervention Improves Self-Care and ... Clinicians can use these results to support caregivers and minimize the potential for burnout. The study randomly assigned 250 patients to the ...

8. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/21/NCT03988621/Prot_SAP_001.pdf

Informal caregiving is demanding and stressful. This ... Informal caregiving is demanding and stressful. This stress may exceed the caregiver's ability to adapt, and many eventually become care recipients ...