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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05613010
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
13 Years - 25 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Mar 19, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mobile health (mHealth) text messaging intervention
    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).

Primary Outcome Measure

Electronically-measured medication adherence (dose taken or not) [ Time Frame: 16 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns HopkinsBaltimoreMaryland21287
Cyd Eaton, PhD
[email protected]
667-306-6201
Cyd Eaton, PhD (PRINCIPAL_INVESTIGATOR)

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