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

NCT ID: NCT03427008

Last Updated: 2021-09-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-30
• 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 immunosuppression medication adherence among adult kidney 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 kidney transplant recipients at the Johns Hopkins Hospital.

Detailed Description

In adult kidney transplant recipients, the leading predictor of rejection, kidney loss, and death is immunosuppressive medication nonadherence. An estimated one-third of kidney transplant recipients reportedly experience medication nonadherence, and even minor deviations from the required protocol have been shown to have negative effects. However, due to the lack of systematic measurements of adherence, the direct relationship between the level of immunosuppressive medication adherence and poor outcomes is not well understood. Therefore, the investigators believe that mHealth technologies could be a feasible way to allow clinicians and researchers to better understand baseline adherence measurements, and increase immunosuppression adherence among kidney transplant recipients.

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, access educational content, and track appointments. 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.

Conditions

Medication Adherence; Transplant; Kidney

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care

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

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 mHealth app and explain its functioning. Participants will then use the application to aid in immunosuppressive medication adherence post-transplant.

Group Type: EXPERIMENTAL

mHealth Intervention

Intervention Type: OTHER

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

Interventions

mHealth Intervention

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults (≥22 years)
• Receive a kidney transplant at the Johns Hopkins Hospital

Exclusion Criteria

• Non-English speaking participants

• 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

Daniel Brennan, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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Reference Type: BACKGROUND

PMID: 7871562 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

Other Identifiers

IRB00164573

Identifier Type: -

Identifier Source: org_study_id