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Trial record 12 of 662 for:    applied AND web-

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

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ClinicalTrials.gov Identifier: NCT01905514
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2013
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Jongwon Ha, Seoul National University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Device: internet mobile application Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients
Study Start Date : September 2013
Actual Primary Completion Date : December 1, 2017
Estimated Study Completion Date : December 31, 2019

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



Primary Outcome Measures :
  1. adherence rate [ Time Frame: up to 6 months ]

Secondary Outcome Measures :
  1. biopsy proven acute rejection rate [ Time Frame: up to 6 months ]

Other Outcome Measures:
  1. renal function [ Time Frame: up to 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905514


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Jongwon Ha, MD, PhD Seoul National University Hospital

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Responsible Party: Jongwon Ha, Professor of, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01905514     History of Changes
Other Study ID Numbers: PRIMA-13-002
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs