Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant

NCT05613010 | Recruiting

• 2 other identifiers: IRB00321009K23DK128573
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Can the investigators create an effective way to improve adherence to immunosuppressant medication and reduce rejection, graft loss, and death in adolescents and young adults who have undergone kidney or liver transplantation? The investigators' mobile technology intervention uses real-time electronic pillbox-assessed dose timing and text message prompts to address antirejection medication nonadherence when nonadherence is detected.

Conditions

Transplant;Failure,Kidney; Transplant; Failure, Liver; Adherence, Medication; Adherence, Patient; Adherence, Treatment

Keywords

kidney transplant; liver transplant; medication adherence; medication nonadherence; compliance; mobile health; mobile phone; technology

Outcome Measures

Primary Outcomes (1)

• Electronically-measured medication adherence (dose taken or not)

  Participants will use an electronic pillbox to assess daily immunosuppressant adherence (tacrolimus or sirolimus), defined as a binary variable: dose taken or not.

  16 months

Secondary Outcomes (1)

• Standard deviation of antirejection medication dose timing

  16 months

Study Arms (1)

Mobile health (mHealth) text messaging intervention

EXPERIMENTAL

During baseline (4 weeks), adherence will be monitored daily via electronic pill boxes and no text messages will be sent. After baseline, participants will begin the 12-week micro-randomized trial of the intervention (a within-person study design). During this 12-week micro-randomized trial, daily adherence will be electronically monitored with the electronic pill boxes and participants will be randomized to receive (1) adherence support text messages or (2) no text message after each missed dose, and (1) praise text message or (2) no text message after each on time dose. For 12 months post-intervention, participants will keep using the electronic pill boxes (no text messages will be sent).

Behavioral: mHealth Messaging Intervention Group

Interventions

mHealth Messaging Intervention Group BEHAVIORAL

Participants will receive an electronic pill box; the research team will instruct participants on how to use this device. Participants will be asked to use the electronic pill box for their prescribed medicines for the duration of the study (up to 16 months). During the 12-week micro-randomized trial, participants will be randomized within person to receive (1) adherence support text messages or (2) no text message after each missed dose, and (1) praise text message or (2) no text message after each on time dose. Dose timing will be determined based on participant report of when they typically take their tacrolimus or sirolimus medicine.

Mobile health (mHealth) text messaging intervention

Eligibility Criteria

• Age: 13 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents and young adults (13-25 years old) who underwent kidney or liver transplantation at least 6 months prior to enrollment
• Currently prescribed tacrolimus or sirolimus.

You may not qualify if:

• Currently receiving dialysis
• Hospitalized for duration of study
• Significant developmental or cognitive delay
• No access to a mobile device that supports text messaging
• Decline to use electronic pill box to monitor daily medication adherence
• Non-English speaking

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Conditions

Medication Adherence; Patient Compliance; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Health Behavior; Behavior

Study Officials

• Cyd Eaton, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cyd Eaton, PhD

CONTACT

667-306-6201; ceaton4@jhmi.edu

Study Design

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

Model Details: This study uses a within-subjects micro-randomized trial design. This study involves randomizing participants within person hundreds of times over to receive intervention or not at each expected dose. Each dose is a decision-point to deliver intervention or not, allowing for within-person comparisons.

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 14, 2022
• Study Start: March 19, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Upon request
• Access Criteria: Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database).

Locations

US (1)