Transplant;Failure,KidneyNCT05613010
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
A study testing mHealth Messaging Intervention Group in people with Transplant;Failure,Kidney and Transplant; Failure, Liver, run by Johns Hopkins University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 13 to 25 years
- Conditions the study is for
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Adherence, Medication
- What is being tested?
- mHealth Messaging Intervention Group
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Adherence, Medication, Adherence, Patient, Adherence, Treatment
- Being tested
- mHealth Messaging Intervention Group
- Keywords
- kidney transplant, liver transplant, medication adherence, medication nonadherence, compliance, mobile health, mobile phone, technology
- Medical subject headings
- Medication Adherence, Patient Compliance, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth Messaging Intervention GroupBehavioural
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 group | Role | What they receive |
|---|---|---|
| Mobile health (mHealth) text messaging intervention | Experimental | 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). Receives: Behavioral: mHealth Messaging Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start19 Mar 2024
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses a within-subjects micro-randomized trial design. This study involves randomizing participants within person hundreds of times over to receive intervention or not at each expected dose. Each dose is a decision-point to deliver intervention or not, allowing for within-person comparisons.
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cyd Eaton, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05613010
- Sponsor's protocol ID
- IRB00321009
- Other IDs
- K23DK128573
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2022
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leveraging Technology to Improve Medication Adherence in Adolescent and Young Adult Kidney or Liver Transplant Recipients: A Micro-Randomized Trial
- ClinicalTrials.gov ID
- NCT05613010
- Acronym / sponsor ID
- IRB00321009
- Conditions
- Transplant;Failure,Kidney, Transplant; Failure, Liver, Adherence, Medication, Adherence, Patient, Adherence, Treatment
- Keywords
- kidney transplant, liver transplant, medication adherence, medication nonadherence, compliance, mobile health, mobile phone, technology
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 14 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses a within-subjects micro-randomized trial design. This study involves randomizing participants within person hundreds of times over to receive intervention or not at each expected dose. Each dose is a decision-point to deliver intervention or not, allowing for within-person comparisons.
| Arm | Type | Receives |
|---|---|---|
| Mobile health (mHealth) text messaging intervention | Experimental | Behavioral: mHealth Messaging Intervention GroupDuring 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). |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth Messaging Intervention GroupParticipants 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. | Behavioural | Mobile health (mHealth) text messaging intervention |
Primary outcome
Electronically-measured medication adherence (dose taken or not)
Time frame: 16 months
Participants will use an electronic pillbox to assess daily immunosuppressant adherence (tacrolimus or sirolimus), defined as a binary variable: dose taken or not.
1 secondary outcome
Standard deviation of antirejection medication dose timing
Time frame: 16 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: Yes. Data from this study will be shared in a de-identified form (i.e., clean, de-identified electronic database) upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cyd Eaton, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth Messaging Intervention Group in people with Transplant;Failure,Kidney and Transplant; Failure, Liver, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electronically-measured medication adherence (dose taken or not) (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.