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

NCT ID: NCT04587024

Last Updated: 2025-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-20
• Study Completion Date: 2023-08-31

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.

Detailed Description

1. STUDY OBJECTIVES 1.1 Primary Objective 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 (22-23).

1.2 Secondary Objectives

• Clinical endpoints including rejection and hospitalization
• Patient reported adherence on immunosuppressant therapy instrument (ITAS)
• Patient-reported QoL outcomes as measured by PedsQL and SF-36
• Patient-reported self-efficacy using the Riekert Self-efficacy scale
• Patient-reported usability using the PSSUQ (treatment arm only)
• To examine the patterns of medication adherence in transplant recipients in both groups to better understand baseline medication adherence
• To understand the feasibility and acceptability of implementing such a system into the clinical workflow and patient follow-up care management

2. BACKGROUND AND RATIONALE In adolescent and adult solid organ transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection, short- and long-term post-transplant complications, and increased healthcare costs (1-8). In transplant recipients, adherence to immunosuppressive drugs, as well as general medical indications is imperative to overall outcomes (9). The rate of non-adherence to immunosuppressive medications in transplant patients varies vastly, with reports ranging from 15-40% in adults and much higher at 50-70% among adolescents (9-14). Additionally, medication adherence is a key concern in the transition from adolescent to adult-centered transplant care, and transition planning should be prioritized in these transplant patients (15-18). Because of lacking objective and accurate non-adherence measurements, both to immunosuppressive drugs and medical indications, the true implications and prevalence of non-adherence is not yet well understood (19-21). Therefore, the investigators believe that mobile health (mHealth) technology has the potential to allow clinicians and researchers to more comprehensively address and understand non-adherence in adolescent and adult transplant recipients.

emocha Mobile Health Inc. has developed an application that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take medications as prescribed and gives providers the assurance that the patients are supported and successful in treatment. DOT is the practice of watching a patient take every dose of medicine in-person, and has typically only been done in extreme cases because it can be both costly and burdensome: DOT is the standard of care for Tuberculosis treatment and has proven high-adherence rates. Through mHealth technology, DOT can be used more broadly and without added burden; emocha's technology allows this through enabling patients to use the mobile application to view the regimen, record themselves taking every dose of the participant's medication, report side effects or symptoms, visualize treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review. The aim of this study is to conduct a randomized control trial to compare medication adherence between patients who use the mHealth system against controls who do not.

Emocha has formally evaluated the mDOT platform across several disease states: tuberculosis, Hepatitis C virus, and opioid use disorder. The U.S. Centers for Disease Control and Prevention (CDC) recognizes emocha's video modality as an acceptable form of DOT, according to the latest guidelines. To date, emocha has partnered with Johns Hopkins and three Maryland health department tuberculosis programs to assess quantitative, qualitative, and cost outcomes associated with emocha video DOT implementation. Among all participants - with more than 1,400 videos submitted thus far - mean patient adherence was 94 percent (median adherence 96 percent, interquartile range 93 to 100 percent). Similar adherence rates were proven in independent studies using emocha performed by Harris County, TX and the Puerto Rico Department of Health. Additionally, emocha is conducting a trial on the feasibility of video DOT for patients undergoing the initiation phase of buprenorphine treatment through office-based opioid treatment programs, as well as conducting ongoing research on Hepatitis C medication adherence among injection drug users.

3. STUDY DESIGN The purpose of this study is to understand how the use of an mHealth application, mDOT, changes medication adherence behaviors among liver or kidney transplant recipients. For the purpose of this research, the mobile app is a device of non-significant risk and exempt from the IDE requirement. emocha Mobile Health is the device manufacturer.

In this multi-center study, patients >/= 13 years of age who receive a liver or kidney transplant at Johns Hopkins Hospital, University of Virginia Medical Center or University of Miami Medical Center will be recruited to participate in this randomized control trial (RCT). There will be 2 arms participants may be randomly assigned to: intervention and control arms. Participants in the intervention arm will receive the mDOT application, and participants in the control arm will not. Both arms will still receive standard of care post-transplant.

Participants are followed for compliance with standard of care recommendations. No additional care or procedures will be administered to study participants. Given the uncertainty in whether this mHealth intervention will improve rates of immunosuppression medication adherence in liver and kidney transplant recipients, a non-treatment group is necessary in order to identify whether an advantage exists.

Conditions

Medication Adherence; Liver Transplantation; Kidney Transplantation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

mHealth intervention

mHealth intervention

Group Type: OTHER

mHealth intervention

Intervention Type: OTHER

Subjects will receive mHealth direct observation of therapy for 12 weeks

standard of care

post-transplant standard of care

Group Type: PLACEBO_COMPARATOR

standard of care

Intervention Type: OTHER

Subjects will receive standard of care observation for 12 weeks

Interventions

mHealth intervention

Subjects will receive mHealth direct observation of therapy for 12 weeks

Intervention Type: OTHER

standard of care

Subjects will receive standard of care observation for 12 weeks

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

> 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

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.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cozumel Pruette, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins University

Baltimore, Maryland, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB00257447

Identifier Type: -

Identifier Source: org_study_id