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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01709097
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : September 4, 2013
Sponsor:
Collaborators:
Addoz
Roche Pharma AG
Tele2Sverige AB
Information provided by (Responsible Party):
Gunnar Tydén, Karolinska University Hospital

Study Description
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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
Medication Adherence Compliance Medication Nonadherence Communication Transplant; Failure, Kidney

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.

Study Design
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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 : June 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? [ Time Frame: 2013 ]

Eligibility Criteria
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Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


Locations
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Sweden
Karolinska University Hospital
Stockholm, Sweden, 14186
Sponsors and Collaborators
Karolinska University Hospital
Addoz
Roche Pharma AG
Tele2Sverige AB
Investigators
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Principal Investigator: Jarmo Henriksson, SC, RN Karolinska University Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gunnar Tydén, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01709097    
Other Study ID Numbers: Dnr 2011/471-31/4
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013
Keywords provided by Gunnar Tydén, Karolinska University Hospital:
Adherence
Compliance
Kidney Transplant Recipient
An electronic drug dispenser
The Portal
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases