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

NCT01709097 | Completed DMC

• 1 other identifier: Dnr 2011/471-31/4
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Adherence; Compliance; Kidney Transplant Recipient; An electronic drug dispenser; The Portal

Outcome Measures

Primary Outcomes (1)

• Can Med-O-Wheel™ improve adherence to the prescribed medication regimen in renal transplant patients?

  2013

Study Arms (2)

With Med-O-Wheel™

Kidney Transplant Recipient with Med-O-Wheel™

With out Med-O-Wheel™

Kidney Transplant Recipient with out Med-O-Wheel™

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Kidney Transplant Recipients in Karolinska University Hospital

Sponsors & Collaborators

• Karolinska University Hospital: lead
• Addoz: collaborator
• Roche Pharma AG: collaborator
• Tele2Sverige AB: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, Stockholm County, 14186, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36094829 DERIVED

MeSH Terms

Conditions

Medication Adherence; Patient Compliance; Communication

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jarmo Henriksson, SC, RN

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 16, 2012
• First Posted: October 17, 2012
• Study Start: June 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 4, 2013

Record last verified: 2013-08

Locations

SE (1)