ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients (PRIMA)

April 18, 2019 updated by: Jongwon Ha, Seoul National University Hospital
Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic rejection and graft failure and it is regarded as a preventable cause of graft loss after solid organ transplantation. The purpose of this study is to evaluate whether mobile application for drug medication can enhance the drug adherence rate.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 year after kidney transplantation
  • out-patient follow up in Seoul National University Hospital
  • using android smartphone
  • taking Prograf as a main immunosuppressant
  • 15-70 years

Exclusion Criteria:

  • patients who cannot use medication event monitoring system
  • multiorgan transplant
  • immunosuppression medication change within 4 weeks of randomization
  • caregiver management of the medication regimen
  • pregnancy
  • patients who can not use mobile application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: control
using Medication event monitoring system
ACTIVE_COMPARATOR: internet mobile application
using both mobile internet application and medication event monitoring system
Device: internet mobile application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adherence rate
Time Frame: up to 6 months
up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
biopsy proven acute rejection rate
Time Frame: up to 6 months
up to 6 months

Other Outcome Measures

Outcome Measure
Time Frame
renal function
Time Frame: up to 6 months
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Jongwon Ha, MD, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ANTICIPATED)

December 31, 2019

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 18, 2013

First Posted (ESTIMATE)

July 23, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2019

Last Update Submitted That Met QC Criteria

April 18, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • PRIMA-13-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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