Adherence, Medication Clinical Trial
Official title:
Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients: A Micro-Randomized 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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2026 |
Est. primary completion date | March 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 - If a participant meets inclusion criteria, enrolls in the study, and experiences graft failure potentially leading to dialysis in the case of kidney transplant recipients, the participant will be given the option to continue in the study if they remain on tacrolimus or sirolimus. |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | 16 months |
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