250 Participants Needed

Virtual Health Coach for Caregiver Stress

(iCare4Me T Trial)

Recruiting at 2 trial locations
KH
AA
Overseen ByAderike Adesanya, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: University of Pennsylvania
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

Trial Summary

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.

What data supports the effectiveness of the treatment Virtual Health Coach for You, iCare4Me, Virtual Caregiver Coach for You?

Research shows that virtual health coaching and internet-based interventions can effectively reduce caregiver stress and improve their quality of life. Studies have found that caregivers using telehealth tools report significant improvements in their outcomes and are generally satisfied with these interventions.12345

How is the Virtual Health Coach for You treatment different from other treatments for caregiver stress?

The Virtual Health Coach for You is unique because it provides a personalized, internet-based program that offers stress management training specifically for caregivers, making it more accessible and tailored compared to traditional in-person therapies.678910

What is the purpose of this trial?

The goal of this randomized controlled trial is to examine the effect of a virtual face-to-face health coach intervention to improve self-care among caregivers of hospitalized older adults during care transitions compared to web-based resource information alone to determine the effectiveness of each intervention. The main questions it aims to answer are:1. compare the efficacy of the virtual health coaching intervention vs. web-based information alone in improving self-care in caregivers of hospitalized community-dwelling older adults with multiple chronic conditions (MCCs) who transition from hospital to home,2. compare outcomes among Black/African American and White caregivers who receive the intervention vs. digital health information alone, and3. explore the estimated the cost of the interventions and acute care resource use among patients of caregivers who received virtual intervention vs. digital health information alone.Participants who enroll will agree to enroll will:* be randomly assigned to either the health information group or the health coaching intervention plus health information group for six months, and* be asked to complete a baseline interview, a check-in call at one month post-hospital discharge, and two follow-up interviews at 3- and 6-months after enrollment.Researchers will compare the two groups of caregivers on the following outcomes: self-care, caregiver self-efficacy (aka confidence), coping, stress, and health status.

Research Team

KH

Karen Hirschman, Ph.D.

Principal Investigator

University of Pennsylvia

Eligibility Criteria

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
See 2 more

Exclusion Criteria

I have no untreated major mental health conditions.
Participation in another similar support or care transition trial
Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual Health Coaching + DHIExperimental Treatment2 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 Control1 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.

Find a Clinic Near You

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+

Findings from Research

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.
Effects of Health and Wellness Coaching With an Adult Cancer Caregiver.Smith, K., Hays, L., Yen, L., 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.
Virtual training and coaching of health behavior: example from mindfulness meditation training.Hudlicka, E.[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.
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]

References

Effects of Health and Wellness Coaching With an Adult Cancer Caregiver. [2022]
Virtual training and coaching of health behavior: example from mindfulness meditation training. [2022]
Reducing caregiver stress with internet-based interventions: a systematic review of open-label and randomized controlled trials. [2022]
A systematic review of telehealth tools and interventions to support family caregivers. [2018]
[An internet-based intervention for health promotion in family caregivers--results of a pilot study]. [2018]
Exploring the effectiveness of an internet-based program for reducing caregiver distress using the iCare Stress Management e-Training Program. [2022]
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. [2023]
Stress in the Volunteer Caregiver: Human-Centric Technology Can Support Both Caregivers and People with Dementia. [2021]
An Interprofessional Virtual Healthcare Neighborhood: Effect on Self-Efficacy and Sleep Among Caregivers of Older Adults With Dementia. [2018]
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. [2022]
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