Recruiting

Family Support

Sponsor:

Wake Forest University Health Sciences

Code:

NCT07661355

Conditions

Care Transition

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Patient-Centered Program

Family Caregiver Enhanced Program

Study Details

Brief summary:

This study investigates better ways to help people after they leave the hospital and how to involve their families in this process. The main goal is to see if adding family support to a patient-centered hospital-to-home intervention helps patients stay safely at home, spend fewer days back in the emergency room or going back into the hospital. The study team also wants to see if the family-centered approach helps improve the patient's ability to do everyday activities without feeling overwhelmed. Two approaches are being compared: one focuses just on the patient, and the other includes special strategies to better support families involved too. Family will be involved in assessing what the patient and family needs. The family-focused approach not only emphasizes the experience, health, and safety of the patient but also the experience of the family member caring for the older adult. The study also involves families in education and provides families skills-building experiences that can help with caregiving stress, problem-solving, and communicating with the healthcare team. The approach will help the family member prepare for their loved one's transition home and provide coaching with the goal of reducing the mental, physical and financial burden of providing care at home. To spread the intervention across many states, the study team will be using telephone calls, video calls, and other technologies as families prefer.

Conditions

Care Transition

Study ID

NCT07661355

Start date

Jul 22, 2026

Status verified date

May, 2026

Completion date

Nov, 2031

Anticipated

Primary completion date

Nov, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Patient Inclusion Criteria:

  • 65 and older
  • English and Spanish speaking
  • Preadmission location: community dwelling
  • Distance from Hospital: Local and Distant (rural) included
  • Cognitive impairment, dementia allowed
  • Technology Literacy: Flexible from high to low
  • EPIC readmission risk score over 12
  • Discharged home

Patient Exclusion Criteria:

  • Admitted from skilled nursing facility
  • Discharged to skilled nursing facility
  • Left Against Medical Advice (AMA)
  • Planned readmission
  • Died during index admission
  • Caregiver unwilling to participate
  • Admitted to surgical services

Caregiver Inclusion Criteria:

  • Adults 18 and older
  • English and Spanish speaking
  • Providing tangible support to patient
  • Distance from Hospital: Local and Distant (rural) included
  • Only Mild Cognitive Impairment allowed
  • Able to be trained in Video Visit Technology
  • Available to support post-discharge

Caregiver Exclusion Criteria:

• Has a greater than a mild cognitive impairment (< 12 on MoCA)

Study Design

Enrollment

2560 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Patient Focused Strategies

An active care transition program that includes effective strategies focused on the patient.

experimental: Patient and Family Focused Strategies

An active care transition program that includes effective strategies focused on the patient plus focused family caregiver engagement and support.

Interventions

Patient-Centered Program

Effective strategies focused on the patient such as patient needs assessment, multi-disciplinary discharge planning, discharge instructions, follow-up education, and follow-up assessments.

Family Caregiver Enhanced Program

Caregiver strategies such as a family caregiver needs assessment, structured education, and skill building.

Primary outcome measure

  • Hospital-Free Days [ Time Frame: Day 60 ]

Central Contacts and Locations

Locations

Davie Medical Center

Recruiting

Bermuda Run, North Carolina, United States, 27006

Contacts

High Point Medical Center

Recruiting

High Point, North Carolina, United States, 27262

Contacts

Atrium Health Wake Forest Baptist Wilkes Medical Center

Recruiting

North Wilkesboro, North Carolina, United States, 28659

Contacts

Atrium Health Wake Forest Baptist Medical Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Sep 21, 2026

Last verified

May, 2026

Keywords

  • hospitalization
  • older adults
  • aging
  • care transition
  • mild cognitive impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.