HEalth Advocate for Liver Transplant - Pilot

NCT05700799 | Recruiting

• 2 other identifiers: 22-36504K23DK132454
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Keywords

Health Advocate; Patient Navigator

Outcome Measures

Primary Outcomes (1)

• Changes in caregiver experience

  The investigators will administer a survey of caregiver experiences at study enrollment and at the end of the intervention to assess for changes in caregiver experience with the transplant team. These questions will focus on experiences receiving transplant care, experiences discussing social needs with the transplant team, and overall caregiver subjective assessment of the transplant recipient's overall health.

  Baseline and 90 days

Secondary Outcomes (3)

• Change in medication adherence using MLVI

  Baseline, 90 days, and 180 days

• The quality of health advocate interactions with the participants, healthcare team, and community-based resources.

  90 days

• A qualitative assessment of caregiver and healthcare provider satisfaction with the Health Advocate intervention.

  90 days

Study Arms (1)

Intervention

EXPERIMENTAL

This is a single arm pilot intervention.

Behavioral: Health Advocate

Interventions

Health Advocate 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.

Also known as: Patient Navigator

Intervention

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients under 18 years if age that have undergone liver transplantation.
• Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.
• Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.
• Patient and/or caregiver felt to be a good fit for this pilot by transplant team.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Patient Navigation

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Sharad Wadhwani, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharad Wadhwani, MD, MPH

CONTACT

510-428-3058; sharad.wadhwani@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 26, 2023
• Study Start: March 20, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)