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

Kidney Transplantation Clinical Trial

— PRIMA  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01905514
• Other study ID #: PRIMA-13-002
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 2013
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 140
• Est. completion date: December 31, 2019
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Device:
• internet mobile application

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	renal function		up to 6 months
Primary	adherence rate		up to 6 months
Secondary	biopsy proven acute rejection rate		up to 6 months