Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™. (C/A)
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|ClinicalTrials.gov Identifier: NCT01709097|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : September 4, 2013
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.
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|
|Medication Adherence Compliance Medication Nonadherence Communication Transplant; Failure, Kidney|
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
Open, prospective, descriptive, randomized study.
Primary research question:
Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?
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.
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.
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 Type :||Observational|
|Actual Enrollment :||80 participants|
|Observational Model:||Case Control|
|Official Title:||Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Kidney Transplant Recipient with Med-O-Wheel™
With out Med-O-Wheel™
Kidney Transplant Recipient with out Med-O-Wheel™
- Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? [ Time Frame: 2013 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01709097
|Karolinska University Hospital|
|Stockholm, Sweden, 14186|
|Principal Investigator:||Jarmo Henriksson, SC, RN||Karolinska University Hospital|