iCare4Me Transitions

NCT06167746 | Recruiting Phase 3 DMC

• 2 other identifiers: R01AG0828921R01AG082892-01
• Study Type: interventional
• Target: 314
• Locations: 1 country
• Sites: 3

Brief Summary

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:

• 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.

Conditions

Caregiver Stress

Keywords

Care Transitions; Older Adult; Health Coaching; Virtual; Self-Care; Coping

Outcome Measures

Primary Outcomes (2)

• Self-Care Inventory

  The Self-Care Inventory (SCI) measures self-care maintenance, monitoring, management, and self-efficacy. Each subscale is standardized on a 0-100 point scale. Higher scores indicate better self-care.

  Collected at: enrollment, 3- and 6-months after enrollment

• Health Self-Care Neglect

  This a binary that scale captures the level of self-care neglect, with higher scores indicating greater neglect.

  Collected at: enrollment, 3- and 6-months after enrollment

Secondary Outcomes (6)

• Perceived Stress Scale

  Collected at: enrollment, 3- and 6-months after enrollment

• Brief COPE

  Collected at: enrollment, 3- and 6-months after enrollment

• Caregiver Self-Care Self-Efficacy Scale

  Collected at: enrollment, 3- and 6-months after enrollment

• Preparedness for Caregiving Scale

  Collected at: enrollment, 3- and 6-months after enrollment

• Quality of the relationship

  Collected at: enrollment, 3- and 6-months after enrollment

Other Outcomes (2)

• Experience with Care

  Collected at 1 month post index-hospital discharge

• Acute care resource use outcomes for patients of caregivers

  Data over 6 months

Study Arms (2)

Digital Health Information (DHI)

ACTIVE COMPARATOR

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

Other: Digital Health Information (DHI)

Virtual Health Coaching + DHI

EXPERIMENTAL

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

Other: Digital Health Information (DHI); Behavioral: Virtual Health Coach for You

Interventions

Digital Health Information (DHI) OTHER

Digital health information websites.

Digital Health Information (DHI); Virtual Health Coaching + DHI

Virtual Health Coach for You 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.

Also known as: ViCCY

Virtual Health Coaching + DHI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Pennsylvania Hospital

Philadelphia, Pennsylvania, 19104-4212, United States

RECRUITING

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Penn Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Karen Hirschman, Ph.D.

  University of Pennsylvia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Hirschman, Ph.D.

CONTACT

215-573-3755; hirschk@nursing.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator will be blinded to group assignment.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized single-group interventional study caregivers of recently hospitalized older adults will receive either digital health information (DHI) alone or a virtual health coaching intervention (Virtual Caregiver Coach for You, ViCCY) with DHI. Health resource data on the patients of the enrolled caregivers will be collected.

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 12, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier. Data will be preserved for at least five years following the end of the grant period.
• Access Criteria: Individual-level data will be shared with controlled access as allowed by informed consent agreements approved by the University of Pennsylvania Institutional Review Board (IRB). Data sharing and confidentiality agreements as established by the university or future data repository will be required.

Locations

US (3)