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

NCT ID: NCT01905514

Last Updated: 2019-04-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2019-12-31

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.

Conditions

Kidney Transplantation

Study Design

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

Study Groups

control

using Medication event monitoring system

Group Type: NO_INTERVENTION

No interventions assigned to this group

internet mobile application

using both mobile internet application and medication event monitoring system

Group Type: ACTIVE_COMPARATOR

internet mobile application

Intervention Type: DEVICE

Interventions

internet mobile application

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jongwon Ha

Professor of

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jongwon Ha, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 36094829 (View on PubMed)

Other Identifiers

PRIMA-13-002

Identifier Type: -

Identifier Source: org_study_id