- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05613010
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
March 19, 2024 updated by: Johns Hopkins University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Over 1/3 of adolescents and young adults who have undergone kidney or liver transplantation are nonadherent to antirejection medicines, accounting for shockingly high rates of infections, rejection, graft loss, and even death.
Recently, the American Society of Transplantation highlighted real-time adherence intervention as top priorities to address antirejection medication nonadherence, but these evidence-based intervention tools do not exist.
The investigators aim to answer the American Society of Transplantation's call and fill these critical gaps in nonadherence management for adolescents and young adults with kidney or liver transplant.
Specifically, electronic pillboxes yield valuable real-time daily dosing data to guide interventions for adolescents and young adult kidney or liver transplant recipients, but existing interventions have not optimally leveraged these devices' capabilities.
Just-in-time adaptive interventions delivered via mobile device (i.e., Smartphone or tablet) are cutting-edge approaches that fully incorporate adolescents and young adults' daily dose behavior to automatically deliver tailored intervention content exactly when adolescents and young adults need it most.
The investigators piloted a promising static medication adherence support text message intervention based on the COM-B model, a well-established behavioral health intervention model, which will be modified into a just-in-time adaptive intervention for adolescents and young adult kidney or liver transplant recipients.
Given that 95% of adolescents and young adults in the USA own smartphones, the investigators hypothesize that the investigators' intervention will improve on-time dosing and reduce rejection, graft loss, and death.
The investigators believe that providing adherence support text messages or praise text messages will result in a higher proportion of adolescents and young adults taking the next dose and maintaining improvements in adherence post-intervention.
In summary, the investigators' just-in-time adaptive intervention leverages real-time electronic pillbox-assessed dosing behavior and Smartphone text messaging capabilities to address tacrolimus or sirolimus nonadherence when nonadherence is detected.
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Cyd Eaton, PhD
- Phone Number: 667-306-6201
- Email: ceaton4@jhmi.edu
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Recruiting
- Johns Hopkins
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Contact:
- Cyd Eaton, PhD
- Phone Number: 667-306-6201
- Email: ceaton4@jhmi.edu
-
Principal Investigator:
- Cyd Eaton, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
11 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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).
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Electronically-measured medication adherence (dose taken or not)
Time Frame: 16 months
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Participants will use an electronic pillbox to assess daily immunosuppressant adherence (tacrolimus or sirolimus), defined as a binary variable: dose taken or not.
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16 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Standard deviation of antirejection medication dose timing
Time Frame: 16 months
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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.
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16 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cyd Eaton, PhD, Johns Hopkins University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 19, 2024
Primary Completion (Estimated)
March 1, 2026
Study Completion (Estimated)
June 1, 2026
Study Registration Dates
First Submitted
November 4, 2022
First Submitted That Met QC Criteria
November 4, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
March 20, 2024
Last Update Submitted That Met QC Criteria
March 19, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00321009
- K23DK128573 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
IPD Sharing Time Frame
Upon request
IPD Sharing Access Criteria
Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database).
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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