iCare4Me Transitions

NCT ID: NCT06167746

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-05-31

Brief Summary

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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, and
3. 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.

Detailed Description

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Conditions

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Caregiver Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Digital Health Information (DHI)

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

Group Type ACTIVE_COMPARATOR

Digital Health Information (DHI)

Intervention Type OTHER

Digital health information websites.

Virtual Health Coaching + DHI

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

Group Type EXPERIMENTAL

Digital Health Information (DHI)

Intervention Type OTHER

Digital health information websites.

Virtual Health Coach for You

Intervention Type BEHAVIORAL

Study participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping.

Interventions

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Digital Health Information (DHI)

Digital health information websites.

Intervention Type OTHER

Virtual Health Coach for You

Study participants in the intervention group will receive 10-session virtual health coaching intervention session delivered over 6 months with the goal of improving caregiver self-care and coping, decreasing stress, and improving the hospital-to-home experience The 10 sessions are on average 60 minutes and cover the following topics: care transitions, caregiving demand, self-care, and coping.

Intervention Type BEHAVIORAL

Other Intervention Names

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ViCCY

Eligibility Criteria

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Inclusion Criteria

* Informal caregiver providing care at least 8 hours/week to the hospitalized older adult (age 65 or older)
* Reporting poor self-care on screening (Health Self-Care Neglect scale score greater than or equal to 2)
* 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

* Cognitive deficits in orientation and/or recall (Six Item Screener score less than 3)
* Participation in another similar support or care transition trial
* Untreated major psychiatric illness (Use of anti-anxiety or anti-depressant medicines is acceptable)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karen Hirschman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvia

Locations

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Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Karen Hirschman, Ph.D.

Role: CONTACT

215-573-3755

Facility Contacts

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Karen Hirschman, PhD MSW FGSA

Role: primary

215-573-3755

Karen Hirschman, PhD

Role: primary

215-573-3755

Karen Hirschman, PhD, MSW

Role: primary

215-573-3755

Other Identifiers

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1R01AG082892-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AG082892

Identifier Type: NIH

Identifier Source: org_study_id

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