Medication Adherence Clinical Trial
— C/AOfficial title:
Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.
Verified date | August 2013 |
Source | Karolinska University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Observational |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | July 2013 |
Est. primary completion date | July 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska University Hospital | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska University Hospital | Addoz, Roche Pharma AG, Tele2Sverige AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? | 2013 | No |
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