Actively Recruiting
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients: A Micro-Randomized Trial
Led by Johns Hopkins University · Updated on 2026-04-13
65
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile technology intervention to improve adherence to immunosuppressant medication in adolescents and young adults who have had kidney or liver transplants. The study addresses the high rates of medication nonadherence in this group, which leads to infections, rejection, graft loss, and death. This trial aims to fill the gap in real-time adherence management using electronic pillboxes and text messaging tailored to daily dosing behavior. Participants will use electronic pillboxes to monitor medication adherence over a 16-month period. The study begins with a 4-week baseline period without text messages. Then, during a 12-week micro-randomized trial, participants will receive either adherence support or no text message after missed doses and either praise or no text message after on-time doses. After this period, participants will continue using the pillboxes for 12 months without further text messages. Throughout the study, adherence is electronically tracked daily, and dosing times are based on participant-reported schedules for tacrolimus or sirolimus. Researchers will measure medication adherence and variability in dosing times over 16 months. The study includes follow-up to monitor adherence and outcomes related to transplant health and safety, with no masking or blinding involved.
CONDITIONS
Brief Title
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adolescents and young adults aged 13 to 25 years
- Had kidney or liver transplantation at least 6 months prior to enrollment
- Currently prescribed tacrolimus or sirolimus medication
You will not qualify if you...
- Currently receiving dialysis
- Hospitalized during the study period
- Significant developmental or cognitive delay
- No access to a mobile device that supports text messaging
- Decline to use electronic pillbox to monitor daily medication adherence
- Non-English speaking
- Participants experiencing graft failure leading to dialysis may continue if still on tacrolimus or sirolimus
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants use an electronic pill box to monitor medication adherence daily without receiving any text messages.
Daily monitoring via electronic pill box
Duration - 12 weeks
Participants continue using the electronic pill box while receiving randomized adherence support or praise text messages based on their medication-taking behavior during a 12-week micro-randomized trial.
Daily monitoring with electronic pill box and text messages
Duration - Up to 12 months
Participants keep using the electronic pill box for medication adherence monitoring without receiving text messages for up to 12 months post-intervention.
Daily monitoring via electronic pill box
Trial Site Locations
Total: 1 location
1
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
Research Team
C
Cyd Eaton, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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