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

This study has been completed.
Sponsor:
Collaborators:
Addoz
Roche Pharma AG
Tele2Sverige AB
Information provided by (Responsible Party):
Gunnar Tydén, Karolinska University Hospital
ClinicalTrials.gov Identifier:
NCT01709097
First received: October 16, 2012
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.

Resource links provided by NLM:


Further study details as provided by Karolinska University Hospital:

Primary Outcome Measures:
  • Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: June 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
With Med-O-Wheel™
Kidney Transplant Recipient with Med-O-Wheel™
With out Med-O-Wheel™
Kidney Transplant Recipient with out Med-O-Wheel™

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.

Primary research question:

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

Efficacy parameters:

P-Creatinine, concentrations of medication (B-tacrolimus, B-cyclosporine, B-sirolimus, P/S-mycophenolate, B-TPMT-metabolites) and age(years).

Addoz Portal for Med-O-Wheel™. Study-specific questionnaire to survey patient discomfort relating to compliance and adherence.

Safety parameters:

Med-O-Wheel™ and Addoz Portal™ is a CE-approved product with a guarantee for continuous operation. Karolinska University Laboratory is an accredited testing laboratory.

Volunteer population

Subjects:

All patients about to undergo renal transplantation at Karolinska University Hospital.

Number: 80 patients (40 patients with Med-O-Wheel™, 40 patients with out Med-O-Wheel™).

Time frame First patient included: Juni 2011. Last patient included: Juli 2012. Last patient completed: Juli 2013.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Kidney Transplant Recipients in Karolinska University Hospital

Criteria

Subject is eligible for the study if the following apply:

  • Receiving a kidney transplant from a deceased or living donor in Karolinska University Hospital
  • Capable of understanding the purpose of the study, fully informed and having written informed consent (signed Informed Consent has been obtained)

No study-specific exclusion criteria

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709097

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Addoz
Roche Pharma AG
Tele2Sverige AB
Investigators
Principal Investigator: Jarmo Henriksson, SC, RN Karolinska University Hospital
  More Information

No publications provided

Responsible Party: Gunnar Tydén, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01709097     History of Changes
Other Study ID Numbers: Dnr 2011/471-31/4
Study First Received: October 16, 2012
Last Updated: August 30, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by Karolinska University Hospital:
Adherence
Compliance
Kidney Transplant Recipient
An electronic drug dispenser
The Portal

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 26, 2014