Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™. (C/A)
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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. |
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated 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 -
- 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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Kidney Transplant Recipients in Karolinska University Hospital
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| Contact: Jarmo Henriksson, RN | +46 8 585 825 64 | jarmo.henriksson@karolinska.se |
| Sweden | |
| Karolinska University Hospital | Recruiting |
| Stockholm, Sweden, 14186 | |
| Contact: Gunnar Söderdahl, Director +46 8 585 87621 gunnar.söderdahl@karolinska.se | |
| 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: | October 16, 2012 |
| 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 May 21, 2013