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

Sponsor

Karolinska University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01709097

Collaborator

Addoz (Other), Roche Pharma AG (Industry), Tele2Sverige AB (Other)

Enrollment

Location

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Compliance Medication Nonadherence Communication Transplant; Failure, Kidney

Detailed Description

Study objectives:

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

adherence to medication regimens,
adherence to appointments at the outpatient clinic, and
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.

Study Design

Study Type:

Observational

Actual Enrollment :

80 participants

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.

Study Start Date :

Jun 1, 2011

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
With Med-O-Wheel™ Kidney Transplant Recipient with Med-O-Wheel™
With out Med-O-Wheel™ Kidney Transplant Recipient with out Med-O-Wheel™

Outcome Measures

Primary Outcome Measures

Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? [2013]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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