iCare4Me Transitions (iCare4Me T)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Caregiver Stress
• Intervention / Treatment: Behavioral: Virtual Health Coach for You; Other: Digital Health Information (DHI)

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Karen Hirschman, Ph.D.; Phone Number: 215-573-3755; Email: hirschk@nursing.upenn.edu
• Study Contact Backup: Name: Aderike Adesanya, MPH; Phone Number: 215-746-3595; Email: aderikea@nursing.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Penn Presbyterian Medical Center
      • Contact: Aderike Adesanya, MPH; Phone Number: 215-746-3595; Email: aderikea@nursing.upenn.edu
      • Contact: Karen Hirschman, PhD, MSW; Phone Number: 215-573-3755; Email: hirschk@nursing.upenn.edu
    • Philadelphia, Pennsylvania, United States, 19104-4212
      • Recruiting
      • Pennsylvania Hospital
      • Contact: Karen Hirschman, PhD MSW FGSA; Phone Number: 215-573-3755; Email: hirschk@nursing.upenn.edu
      • Contact: Aderike Adesanya, MPH; Phone Number: 2157463595; Email: aderikea@nursing.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Digital Health Information (DHI); Digital health information websites.
Experimental: Virtual Health Coaching + DHI; Study participants in the intervention group will receive 10-session virtual health coaching intervention sessions delivered over 6 months.	Behavioral: 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.; Other Names: ViCCY; Other: Digital Health Information (DHI); Digital health information websites.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	The perceived stress scale has 10 items rated on a 5-point scale rating perceptions of stress.	Collected at: enrollment, 3- and 6-months after enrollment
Brief COPE	This tool is designed to assess the varying coping strategies used by individuals in response to stress.	Collected at: enrollment, 3- and 6-months after enrollment
Caregiver Self-Care Self-Efficacy Scale	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.	Collected at: enrollment, 3- and 6-months after enrollment
Preparedness for Caregiving Scale	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.	Collected at: enrollment, 3- and 6-months after enrollment
Quality of the relationship	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.	Collected at: enrollment, 3- and 6-months after enrollment
RAND Medical Outcomes Study Short Form (SF-36)	This scale that uses multiple measures to determine overall mental and physical health. Higher scores indicate better mental and physical health.	Collected at: enrollment, 3- and 6-months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Experience with Care	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.	Collected at 1 month post index-hospital discharge

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Karen Hirschman, Ph.D., University of Pennsylvia

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: December 4, 2023
• First Submitted That Met QC Criteria: December 4, 2023
• First Posted (Actual): December 12, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Virtual; Coping; Health Coaching; Self-Care; Older Adult; Care Transitions
• Other Study ID Numbers: R01AG082892 (U.S. NIH Grant/Contract); 1R01AG082892-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant self-report data collected during the trial that underlie the results of the primary outcome will be shared after de-identification.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No