NCT01905514

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2013

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

4.3 years

First QC Date

July 18, 2013

Last Update Submit

April 18, 2019

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • adherence rate

    up to 6 months

Secondary Outcomes (1)

  • biopsy proven acute rejection rate

    up to 6 months

Other Outcomes (1)

  • renal function

    up to 6 months

Study Arms (2)

control

NO INTERVENTION

using Medication event monitoring system

internet mobile application

ACTIVE COMPARATOR

using both mobile internet application and medication event monitoring system

Device: internet mobile application

Interventions

internet mobile applicationDEVICE
internet mobile application

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (1)

  • Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.

    PMID: 36094829DERIVED

Study Officials

  • Jongwon Ha, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 23, 2013

Study Start

September 1, 2013

Primary Completion

December 1, 2017

Study Completion

December 31, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Locations

KR(1)