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

Seoul National University

Status: Unknown

Conditions: Kidney Transplantation

Treatments: Device: internet mobile application

Study type: Interventional

Funder types: Other

Identifiers

NCT01905514

PRIMA-13-002

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

control

No Intervention group

Description:

using Medication event monitoring system

internet mobile application

Active Comparator group

Description:

using both mobile internet application and medication event monitoring system

Treatment:

Device: internet mobile application