HEalth Advocate for Liver Transplant - Pilot

NCT ID: NCT05700799

Last Updated: 2025-08-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2027-06-30

Brief Summary

The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.

Conditions

Liver Transplant; Complications; Pediatric ALL

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Intervention

This is a single arm pilot intervention.

Group Type: EXPERIMENTAL

Health Advocate

Intervention Type: BEHAVIORAL

The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination.

Interventions

Health Advocate

The Health Advocate intervention will include helping pediatric liver transplant recipients and their families address unmet household social needs (e.g., food insecurity), improve patient-provider communication, and enhance care coordination.

Intervention Type: BEHAVIORAL

Other Intervention Names

Patient Navigator

Eligibility Criteria

Inclusion Criteria

1. Patients under 18 years if age that have undergone liver transplantation.

2. Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.

3. Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.

4. Patient and/or caregiver felt to be a good fit for this pilot by transplant team.

Exclusion Criteria

• Caregiver unwilling or unable to complete the survey.
• Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.
• Non-English, non-Spanish speakers.
• Non-US residents.
• Greater than 18 years of age at the time of enrollment.

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharad Wadhwani, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sharad Wadhwani, MD, MPH

Role: CONTACT

sharad.wadhwani@ucsf.edu

510-428-3058

Facility Contacts

Emily Stekol

Role: primary

emily.stekol@ucsf.edu

415-502-3190

Other Identifiers

K23DK132454

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-36504

Identifier Type: -

Identifier Source: org_study_id