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

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen by Cozumel Pruette, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

Trial Summary

What is the purpose of this trial?

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

You have a smartphone and are okay with receiving information on it.

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.

Treatment Details

Interventions

• mHealth intervention (Behavioural Intervention)

Participant Groups

Group I: mHealth intervention Experimental Treatment 1 Intervention

mHealth intervention

Group II: standard of care Placebo Group 1 Intervention

post-transplant standard of care

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Johns Hopkins Baltimore, MD

University of Miami Miami, FL

University of Virginia Charlottesville, VA

Johns Hopkins University Baltimore, MD

Who Is Running the Clinical Trial?

Johns Hopkins University Lead Sponsor

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

References