N/A N=70 Randomized Double-blind Other

A Study of mDOT for Immunosuppressant Adherence in Solid Organ Transplant Recipients

Medication Adherence · Liver Transplantation · Kidney Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT04587024 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2025

Primary outcome: Primary: Medication Adherence Via Medication Level Variability Index (MLVI) — 23; 24; 10; 8 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: mHealth intervention (Other); standard of care (Other)
Age: Pediatric, Adult, Older Adult · 13+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Medication Adherence Via Medication Level Variability Index (MLVI)	23; 24; 10; 8; 3; 2	—
SECONDARY Blood Tacrolimus Levels	2.6; 2.37	—
SECONDARY Patient Reported Adherence	12; 11	—
SECONDARY Patient Reported QoL as Assessed by the PedsQL	—	—
SECONDARY mHealth Usability Measurement	1.57	—
SECONDARY Patterns of Medication Adherence	—	—
SECONDARY Provider Workflow as Assessed by Patient Usage of the mDOT App	—	—
SECONDARY Patient Reported QoL as Assessed by the SF-36	—	—

Summary

In solid organ transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection (needing a new transplant), post-transplant complications, and increased healthcare costs. Additionally, nonadherence to immunosuppressant medications is imperative to short- and long-term outcomes. The rate of nonadherence in this population varies vastly. Because of lacking objective and accurate nonadherence measurements, both to immunosuppressant drugs and medical indications, the true implications and prevalence of nonadherence is not yet well understood. Therefore, investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand nonadherence in solid organ transplant recipients. The aim of this study is to conduct a randomized control trial to compare medication adherence among liver and kidney transplant patients who use the mHealth system against controls who do not.

Eligibility Criteria

Inclusion Criteria

Participants must meet all of the following inclusion criteria to participate in this study:

> 13 years old Own a smart phone and are willing to receive information through it Received a liver or kidney transplant at a participating study site during or prior to the study period.

Exclusion Criteria

All candidates meeting any of the following exclusion criteria at baseline will be excluded from study participation:

Patients with cognitive impairments will not be eligible for enrollment due to inability to provide informed consent.

Inability or unwillingness of individual or legal guardian/representative to give consent.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04587024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.