Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant

NCT05260268 | Recruiting DMC

• 1 other identifier: 849575
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

Liver transplantation is increasingly performed for older adults with multiple comorbidities. Medication adherence is key to maintaining proper function of the transplanted liver and optimize health; however, adhering to post-transplant treatment is complex. This trial will study how available technology combined with transplant center resources and caregiver support can optimize medication adherence, quality of life, and health outcomes among new liver transplant recipients at 3 centers.

Conditions

Liver Transplant; Complications; Cirrhosis; End Stage Liver DIsease; Medication Adherence

Outcome Measures

Primary Outcomes (1)

• 24 Hour Recall

  Patient self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients will also be asked about the medical indication for each drug. Correct dosing will be measured as a yes/no per drug, having properly shown dose (number of pills), spacing (hours between doses), frequency (times per day), and total pills/day.

  18 Months

Secondary Outcomes (12)

• Tacrolimus Lab Values, ng/mL

  18 Months

• ASK-12

  18 Months

• EQ-5D-5L

  18 Months

• Alcohol, Tobacco, and Drugs Survey

  18 Months

• 30-Second Chair Stand, seconds

  18 Months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care refers to the normal standard clinical practices immediately post-transplant to the 18 months following. Liver Transplant Recipients at sites have lab values taken weekly for the first 8-10 weeks post-transplant, shifting to every 2-4 weeks for the next 3-4 months, then monthly to every 3 months thereafter depending on clinical needs. All sites follow a similar schedule of tapering clinic visits ranging from weekly in the first 4 weeks to every 2-4 weeks in months 4-6, every 3-6 months in months 7 12, and every 6 months in months 12-24. All sites assign each patient to a specific transplant coordinator, first paired with a transplant surgeon (first 3-6 months), and then a transplant hepatologist for the remainder of follow-up. All patients and caregivers receive standard medication teaching prior to hospital discharge and then ad hoc. No routine text message reminders, caregiver reminders, or adherence alerts are used in usual care.

TEST Intervention

EXPERIMENTAL

Clinical activities for Usual Care will also be provided in the TEST arm. The TEST intervention is a technology-enabled strategy to routinely monitor regimen use, adherence, and persistence via a 'low touch', easy to use, online behavioral toolkit - Way to Health . It was developed by University of Pennsylvania researchers to automate behavioral intervention. The TEST approach includes monthly adherence assessments, with tailored adherence support. The following components will be included in the intervention: * Monthly W2H Adherence Assessment \& Clinician Alerts * Medication Reminders * Laboratory and Appointment Notifications * Supplemental Self-Management Support

Behavioral: TEST Intervention

Interventions

TEST Intervention BEHAVIORAL

The TEST intervention will include standard post-transplant care and include additional touchpoints utilizing the Way to Health system. Details on this intervention are included in the study arm description.

TEST Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Within 3 months of liver transplant
• English or Spanish-speaking
• Home-dwelling\*
• Patient or care partner owns a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.
• \*The definition of "home" includes hotel or short-term housing. Patients who are going to a rehabilitation or skilled nursing facility (SNF) immediately after transplant may still be recruited if the site-PI/Co-I determines they are likely to be discharged to home within 3 months post-transplant.
• years or older
• English or Spanish speaking
• Care partner has access to a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.

You may not qualify if:

• Liver transplant recipient who speaks neither English nor Spanish
• Any severe uncorrectable vision, hearing, or cognitive impairments that may impede study interviews
• Care partner who speaks neither English nor Spanish

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (3)

University of Miami

Miami, Florida, 33146, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60208, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (1)

• Serper M, Burdzy A, Schaubel DE, Mason R, Banerjee A, Goldberg DS, Martin EF, Mehta SJ, Russell LB, Cheung AC, Ladner DP, Yoshino Benavente J, Wolf MS. Patient randomised controlled trial of technology enabled strategies to promote treatment adherence in liver transplantation: rationale and design of the TEST trial. BMJ Open. 2023 Sep 18;13(9):e075172. doi: 10.1136/bmjopen-2023-075172.

  PMID: 37723108 DERIVED

MeSH Terms

Conditions

Fibrosis; End Stage Liver Disease; Medication Adherence

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Marina Serper, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Mason, PharmD

CONTACT

(215) 662-3904; richard.mason@pennmedicine.upenn.edu

Marina Serper, MD

CONTACT

(215) 349-8222; marinas2@pennmedicine.upenn.edu

Study Design

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

Model Details: This is a longitudinal intervention study utilizing diverse cohorts of liver transplant recipients. It is a 2-arm, patient-randomized controlled trial of de novo liver transplant recipients.

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: March 2, 2022
• Study Start: December 1, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)