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Behavioural Intervention

Virtual Health Coaching + DHI for Caregiver Stress (iCare4Me T Trial)

Phase 3

Recruiting

Led By Karen Hirschman, Ph.D.

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected at: enrollment, 3- and 6-months after enrollment

Awards & highlights

iCare4Me T Trial Summary

This trial will compare the effectiveness of a virtual health coach intervention and digital health information to improve self-care among caregivers of hospitalized older adults transitioning from hospital to home.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves digital information and virtual coaching rather than medication or medical procedures, traditional side effects are not expected. However, participants may experience increased screen time which could lead to eye strain or headache.

iCare4Me T Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ collected at: enrollment, 3- and 6-months after enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~collected at: enrollment, 3- and 6-months after enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected at: enrollment, 3- and 6-months after enrollment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Health Self-Care Neglect

Self-Care Inventory

Secondary outcome measures

Brief COPE

Caregiver Self-Care Self-Efficacy Scale

Perceived Stress Scale

+3 more

Other outcome measures

Experience with Care

iCare4Me T Trial Design

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,787 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,676 Previous Clinical Trials

28,021,249 Total Patients Enrolled

3 Trials studying Caregiver Stress

435 Patients Enrolled for Caregiver Stress

Karen Hirschman, Ph.D.Principal InvestigatorUniversity of Pennsylvia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential hazards associated with Intervention Group?

"A score of 3 was allocated to Intervention Group's safety due to the multiple rounds of data, which were obtained from a Phase 3 trial that demonstrated efficacy."

Answered by AI

Is enrollment available to participants for this clinical experiment?

"Based on the clinicaltrials.gov page, it appears that recruitment for this study has been closed since December 4th 2023 - despite initially being posted March 1st 2024. However, 7 other trials are still recruiting patients at present."

Answered by AI

What benefits are expected to be gained from this experiment?

"This clinical trial has Health Self-Care Neglect as its primary outcome, with three secondary goals: measuring the coping strategies of patients via Brief COPE, Caregiver Self-Care Self-Efficacy Scale and Preparedness for Caregiving Scale. Outcome measurements will occur at enrollment, 3 months post enrollment and 6 months post enrolment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

iCare4Me Transitions

2024. "iCare4Me Transitions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06167746.