iCare4Me Transitions

Caregiver Stress Clinical Trial

— iCare4Me T  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06167746
• Other study ID #: R01AG082892
• Secondary ID: 1R01AG082892-01
• Status: Recruiting
• Phase: Phase 3
• Start date: March 1, 2024
• Est. completion date: May 31, 2028

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Karen Hirschman, Ph.D.
• Phone: 215-573-3755
• Email: hirschk[@]nursing.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: May 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Caregiver Stress

Intervention

Other:
• Digital Health Information (DHI)
Digital health information websites.

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.

Locations

Country	Name	City	State
United States	Penn Presbyterian Medical Center	Philadelphia	Pennsylvania
United States	Pennsylvania Hospital	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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