Medication AdherenceC/ANCT01709097
Compliance/Adherence After Kidney Transplant, With or With Out Med-O-Wheel™.
An observational study of Medication Adherence and Compliance, run by Karolinska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medication Adherence, Compliance, Medication Nonadherence
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2011to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.
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.
Read more
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.
Read the 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.
- Conditions
- Medication Adherence, Compliance, Medication Nonadherence, Communication, Transplant; Failure, Kidney
- Keywords
- Adherence, Compliance, Kidney Transplant Recipient, An electronic drug dispenser, The Portal
- Medical subject headings
- Medication Adherence, Patient Compliance, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| With Med-O-Wheel™ | Kidney Transplant Recipient with Med-O-Wheel™ | |
| With out Med-O-Wheel™ | Kidney Transplant Recipient with out Med-O-Wheel™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?
Measured: 2013
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2012 (estimated)
- Study startJun 2011
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Addoz, Roche Pharma AG, Tele2Sverige AB
- Responsible party
- Principal investigator, Gunnar Tydén, Karolinska University Hospital
- Investigators
- Jarmo Henriksson, SC, RN, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01709097
- Sponsor's protocol ID
- Dnr 2011/471-31/4
- Acronym
- C/A
- Status last verified
- Aug 2013
- First submitted
- 16 Oct 2012
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PubMed 36094829
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance/Adherence After Kidney Transplant, With or With Out an Electronic Drug Dispenser(Med-O-Wheel™), Karolinska University Hospital.
- ClinicalTrials.gov ID
- NCT01709097
- Acronym / sponsor ID
- C/A / Dnr 2011/471-31/4
- Conditions
- Medication Adherence, Compliance, Medication Nonadherence, Communication, Transplant; Failure, Kidney
- Keywords
- Adherence, Compliance, Kidney Transplant Recipient, An electronic drug dispenser, The Portal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Addoz, Roche Pharma AG, Tele2Sverige AB
- Study start
- Jun 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 17 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Med-O-Wheel™ | – | –Kidney Transplant Recipient with Med-O-Wheel™ |
| With out Med-O-Wheel™ | – | –Kidney Transplant Recipient with out Med-O-Wheel™ |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney Transplant Recipients in Karolinska University Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?
Time frame: 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2013.
- Derived from this study: PubMed 36094829Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jarmo Henriksson, SC, RN principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medication Adherence and Compliance, run by Karolinska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients? (time frame: 2013). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01709097, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2013.