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NCT Number: NCT06167746

iCare4Me Transitions

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.

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Key information

Conditions

Caregiver Stress Behavior Behavioral Symptoms Caregiver Burden Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Digital Health Information (DHI)

Other

Digital health information websites.

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.

Other names: ViCCY

Primary outcomes

  1. Self-Care Inventory

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

    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.

  2. Health Self-Care Neglect

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

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

Secondary outcomes

  1. Perceived Stress Scale

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

    The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.

  2. Brief COPE

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

    This tool is designed to assess the varying coping strategies used by individuals in response to stress.

  3. Caregiver Self-Care Self-Efficacy Scale

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

    This scale measures caregiving self-efficacy in multiple areas. Each item is measured on a scale of 1-5 with 5 indicating they are the most confident in that area.

  4. Preparedness for Caregiving Scale

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

    This scale measures how prepared caregivers feel to provide support for their loved ones in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most prepared in that area.

  5. Quality of the relationship

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

    This scale measures giving and receiving support in multiple areas. Each item is measured on a scale of 0-4 with 4 indicating they are the most positive in that area.

  6. RAND Medical Outcomes Study Short Form (SF-36)

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

    This scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health.

Other outcomes

  1. Experience with Care

    Time frame: Collected at 1 month post index-hospital discharge

    This 10-item tool evaluates the experience with care post-hospital discharge. Each item is measured on a scale of 1-4 with 4 indicating they strongly agree with each statement.

  2. Acute care resource use outcomes for patients of caregivers

    Time frame: Data over 6 months

    Hospitalizations and emergency department visits or the patients of caregivers during the 6 months after the caregiver enrolls.

Study contacts

Contact information is provided by the study sponsor or research team.

Karen Hirschman, Ph.D.

CONTACT

[email protected]

215-573-3755

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Improving Care Transitions and Self-care Among Informal Caregivers of Hospitalized Older Adults Through Digital Tools

Acronym: iCare4Me T

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Dec 12, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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