NCT04587024

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

Completed NA Results posted Last updated 10 February 2025

What this trial tests

NA trial testing mHealth intervention in Medication Adherence in 75 participants. Completed in 31 August 2023.

Timeline

20 November 2020

Primary endpoint
31 August 2023

31 August 2023

Quick facts

Lead sponsor	Johns Hopkins University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	75
Start date	20 November 2020
Primary completion	31 August 2023
Estimated completion	31 August 2023
Sites	2 locations across United States

Drugs / interventions tested

• mHealth intervention
• standard of care

Conditions studied

• Medication Adherence — all drugs for Medication Adherence →
• Liver Transplantation — all drugs for Liver Transplantation →
• Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Johns Hopkins University

Who can join

13 and older, any sex, with Medication Adherence or Liver Transplantation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence Via Medication Level Variability Index (MLVI) Primary · 3 months

To compare medication adherence of solid organ transplant recipients, specifically liver and kidney transplants, using the mobile DOT (mDOT) application (i.e., intervention) to those who did not use the mDOT application (i.e., control). The investigators will compare medication adherence between intervention and control arms using the Medication Level Variability Index (MLVI), a validated measure of adherence derived from the standard deviation of measured drug levels. The investigators will look at the difference in MLVIs between the two solid organ transplant groups. MLVI is the standard dev

Group	Value	95% CI
mHealth Intervention	23
Standard of Care	24
mHealth Intervention	10
Standard of Care	8
mHealth Intervention	3
Standard of Care	2

Blood Tacrolimus Levels Secondary · 3 months

Clinical endpoint measuring the blood levels of tacrolimus (in ng/ml) that indicate rejection of transplant or not

Group	Value	95% CI
mHealth Intervention	2.6	± 0.87
Standard of Care	2.37	± 1.07

Patient Reported Adherence Secondary · 3 months

Patient reported adherence depending on their scores from the immunosuppressant therapy instrument (ITAS questionnaire) will be measured. The ITAS is a four-item questionnaire that asks respondents to indicate how often they were non-adherent to immunosuppressant therapy (IST) given a particular circumstance. They are asked how often they: (i) forgot to take their IST medications; (ii) were careless about taking their IST medications; (iii) stopped taking their IST medications because they felt worse; and (iv) missed taking their IST medications for any reason. This is a binary measure where A

Group	Value	95% CI
mHealth Intervention	12	± 2
Standard of Care	11	± 2

mHealth Usability Measurement Secondary · 3 months

Patient-reported usability measured using the Post-Study System Usability Questionnaire (PSSUQ), a 16-item questionnaire that follows a 7-point Likert Scale. The scale starts with 1 (strongly agree) and ends with 7 (strongly disagree). The overall result is calculated by averaging the scores from the 7 points of the scale, for all 16 items. The lower the score, the better the usability and satisfaction. Median likert scale choice is reported. This will be done in the mHealth intervention arm only.

Group	Value	95% CI
mHealth Intervention	1.57	± 1.47

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.