A Pilot Study of mDOT for Immunosuppressant Adherence in Adult Liver Transplant Recipients

NCT ID: NCT03515330

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2020-11-12

Brief Summary

The investigators are interested in whether or not the use of a mobile health (mHealth) application increases the rate of immunosuppressant medication adherence among adult liver transplant recipients. The investigators aim to test this by randomly assigning transplant recipients to the intervention (use of an mHealth app to manage and track their immunosuppression regimen) or control arm (standard of care) upon discharge from their initial transplant hospitalization, and tracking medication adherence over time. The study population will be approximately 50 adult liver transplant recipients at the Johns Hopkins Hospital.

Detailed Description

In adult transplant recipients, poor adherence to immunosuppressant medications carries the risk of graft rejection, post-transplant complications, and increased healthcare costs. In adult liver transplant recipients, adherence to immunosuppressant drugs, as well as to general medical indications (e.g. avoiding alcohol intake), is imperative to short- and long-term outcomes. The rate of non-adherence to immunosuppressant medications in this population varies vastly, with reports ranging from 15-40%. Because of lacking objective and accurate non-adherence measurements, the true implications and prevalence of non-adherence is not yet well understood. 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 adult liver transplant recipients. Additionally, an mHealth application with the ability to track symptoms, side effects, and alcohol cravings could provide clinicians with valuable information on post-transplant care.

We will use a mobile health platform that enables users to track dose-by-dose medication adherence through asynchronous, video directly observed therapy (DOT). This helps patients take their medication as prescribed and gives providers the assurance that their 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 their mobile application to view their regimen, record themselves taking every dose of their medication, report side effects or symptoms, visualize their 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 application against controls who do not.

Conditions

Medication Adherence; Liver Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard of Care

Participants in the control arm will be instructed to take their immunosuppressant medications as prescribed and attend required follow-up as is standard of care, and will not receive the mHealth application.

Group Type: NO_INTERVENTION

No interventions assigned to this group

mHealth Intervention

Participants in the intervention arm will receive the mHealth app either while they are an inpatient post-transplant, or at their first post-transplant clinic visit. Study personnel will assist participants assigned to the mHealth intervention arm with downloading the application and explain its functioning. Participants will then use the application to aid in immunosuppressant medication adherence post-transplant.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: OTHER

The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.

Interventions

mHealth Intervention

The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Greater than or equal to 22 years of age
• Receive a liver transplant at Johns Hopkins Hospital

Exclusion Criteria

• Non-English speaking liver transplant recipients

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Macey Henderson, JD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Andrew Cameron, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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Other Identifiers

IRB00173000

Identifier Type: -

Identifier Source: org_study_id