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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-25
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Currently receiving dialysis

Hospitalized for duration of study

Significant developmental or cognitive delay

No access to a mobile device that supports text messaging

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: Mobile health (mHealth) text messaging interventionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
16 months

Secondary outcomes

1

Standard deviation of antirejection medication dose timing

This metric will be calculated as each participants' standard deviation (SD) in tacrolimus or sirolimus daily dose timing during the study based on how many minutes early/late tacrolimus or sirolimus was timestamped as taken (administered) from when it is prescribed (e.g., how many minutes before/after AYA's expected dose time) using time stamp data from the electronic pill boxes.

Time frame
16 months

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator