Recruiting
Phase 3

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06167746

Conditions

Caregiver Stress

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Digital Health Information (DHI)

Virtual Health Coach for You

Study Details

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:

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.

Conditions

Caregiver Stress

Study ID

NCT06167746

Start date

Mar 1, 2024

Status verified date

Mar, 2026

Completion date

May 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

314 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

experimental: Virtual Health Coaching + DHI

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

Interventions

Digital Health Information (DHI)

Digital health information websites.

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.

Primary outcome measure

  • Self-Care Inventory [ Time Frame: Collected at: enrollment, 3- and 6-months after enrollment ]
  • Health Self-Care Neglect [ Time Frame: Collected at: enrollment, 3- and 6-months after enrollment ]

Central Contacts and Locations

Central contacts

Locations

Pennsylvania Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4212

Contacts

Karen Hirschman, PhD MSW FGSA

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

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Penn Presbyterian Medical Center

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-12.