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

NCT04587024 | Completed Results DMC

• 1 other identifier: IRB00257447
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Medication Adherence; Liver Transplantation; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Medication Adherence Via Medication Level Variability Index (MLVI)

  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 deviation of a series of at least three trough blood levels of tacrolimus or sirolimus. Higher MLVI value indicates greater variability in medication levels. MLVI \>=2 is suggestive of nonadherence and MLVI \<2 suggestive of adherence.

  3 months

Secondary Outcomes (7)

• Blood Tacrolimus Levels

  3 months

• Patient Reported Adherence

  3 months

• Patient Reported QoL as Assessed by the PedsQL

  12 months

• mHealth Usability Measurement

  3 months

• Patterns of Medication Adherence

  12 months

Study Arms (2)

mHealth intervention

OTHER

mHealth intervention

Other: mHealth intervention

standard of care

PLACEBO COMPARATOR

post-transplant standard of care

Other: standard of care

Interventions

mHealth intervention OTHER

Subjects will receive mHealth direct observation of therapy for 12 weeks

mHealth intervention

standard of care OTHER

Subjects will receive standard of care observation for 12 weeks

standard of care

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Challenges with recruitment in the setting of COVID pandemic.

Results Point of Contact

• Title: Dr. Cozumel S. Pruette
• Organization: Johns Hopkins University

csouthe1@jhmi.edu

410-955-2467

Study Officials

• Cozumel Pruette, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 14, 2020
• Study Start: November 20, 2020
• Primary Completion: August 31, 2023
• Study Completion: August 31, 2023
• Last Updated: February 10, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)