MedTrace Logo

Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.

NCT01709097 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2013-09-04

No results posted yet for this study

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.

Conditions

  • Medication Adherence
  • Compliance
  • Medication Nonadherence
  • Communication
  • Transplant; Failure, Kidney

Sponsors & Collaborators

  • Addoz

    collaborator OTHER

  • Roche Pharma AG

    collaborator INDUSTRY

  • Tele2Sverige AB

    collaborator UNKNOWN

  • Karolinska University Hospital

    lead OTHER

Principal Investigators

  • Jarmo Henriksson, SC, RN · Karolinska University Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01709097 on ClinicalTrials.gov