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Clinical Trials/NCT01709097
NCT01709097CompletedNot Applicable

Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.

Karolinska University Hospital1 site in 1 country80 target enrollmentStarted: June 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
80
Locations
1
Primary Endpoint
Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?

Study Overview

Brief Summary

Background:

Adherence to the immunosuppressive drug regimen is critical to the outcome after an organ transplant. Patients need to take their prescribed medications and attend their appointments with the doctor.

Based on previous studies in other European countries, the cost of non-compliance after organ transplantation in Sweden is >SEK 35 million/year.

Patients who lose their graft both lose quality of life and have decreased expected survival; moreover, retransplantation may be hampered by new HLA antibodies.

Question:

The primary question is whether Med-O-Wheel™ can improve compliance to the prescribed medication regimen in renal transplant patients.

Methods and materials:

All kidney transplant patients at Karolinska University Hospital, Huddinge, will be given information about the study and will then be asked to participate. Participants will be randomized into two arms, one arm with and one with out Med-O-Wheel™. The 80 included patients will be closely monitored for 1 year regarding intake of prescribed medications.

Med-O-Wheel™ is an electronic medication dispenser that records the date and time of each occasion when the patient takes medications from the dispenser. It has a SIM card and text messaging capabilities.

Addoz Portal™ is a web-based application that makes it possible to monitor and analyse medication intake. Each event in the medication dispenser is registered in the portal, which communicates with the care provider/support person by text message, e-mail or telephone.

Significance of the study:

In the future it may be possible to improve compliance in transplant patients. In particular, patients will feel secure since they will receive confirmation through the portal that they are taking their medications safely and accurately.

Detailed Description

Study objectives:

To investigate whether Med-O-Wheel™ can improve -

  1. adherence to medication regimens,
  2. adherence to appointments at the outpatient clinic, and
  3. treatment outcome in renal transplant patients. Methodology

Study design:

Open, prospective, descriptive, randomized study.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?

Time Frame: 2013

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Karolinska University Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gunnar Tydén

Professor

Karolinska University Hospital

Study Sites (1)

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