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Completed
NCT04190251
PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Conditions: Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 73
Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Location: Centre Hospitalier Universitaire Vaudois Lausanne Canton of Vaud
Summary
Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.
Eligibility Criteria
Inclusion criteria:
* MDRD or CKD-EPI eGFR ≤60 ml/min/1.73m2 or albumin/creatinin \>30mg/mmol
* Type 2 diabetes
* At least one medication in the following list : oral antidiabetics and/or statins and/or antihypertensive drugs and/or aspirin
* Patients speaking french, english or italian or interpreter present at each pharmacy visit
* Patients have to sign the written consent form
* Patients have to agree to use the Electronic Monitoring system (EM, named MEMS®; Aardex Ltd)
* Complete laboratory exams in the last 6 months: eGFR and HbA1c and (albumin/creatinin ratio or total cholesterol + LDL + HDL)
Exclusion Criteria:
* Not being able to understand or sign the consent form
* Pregnancy
* Recent cancer diagnosis
* Cognitive disorder
* The subject does not manage the treatment alone
Source: ClinicalTrials.gov (NCT04190251). StuddyBuddy aggregates publicly available trial information.