PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program

N/ACompletedNCT04190251

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland73 enrolled

Overview

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.

In addition to usual care, patients are included in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is held by the Unisanté's community pharmacists\*, in coordination with medical and nurse staff , to support medication adherence and to promote the continuity of care. For patients not speaking french, english, or italian, the interviews will be done with a interpreter. The medication adherence data will be analysed in both groups along with clinical data obtained through draw samples regularly prescribed by the physician. \*Since the 1st January 2019, the Policlinique Médicale Universitaire became Unisanté, University Center for Primary Care and Public Health (Lausanne, Switzerland).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Inteprofessional medication adherence support program (IMAP)OTHER

In addition to usual care, patients participate in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is done by the Unisanté's community pharmacists, in coordination with medical and nurse staff , to support medication adherence and to promote continuity of care. The intervention is held at the Unisanté's community pharmacy. For patients not speaking french, english, or italien, the interviews will be done with a interpreter.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Medication adherence (longitudinal data)

Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months)

Time frame: 24 months

Secondary Outcomes

Clinical outcomes

ADVANCE kidney score

Time frame: Baseline, 6 monts and 12 months post-intervention

Clinical outcomes

UKPDS score

Time frame: Baseline, 6 monts and 12 months post-intervention

Medication adherence

Number of patients with an electronic medication adherence ≤ 30% for at least one medication throughout two successive pharmacy visits during the post-intervention phase

Time frame: 6 months or 12 months post-intervention phase

Patients' satisfaction

In depths and semi-structured interviews to assess patient's opinions about the program

Time frame: At 6 months or 12 months (end of the intervention phase) or at the stop of the study (24 months if the patient ends the study or between the end of the intervention phase (6 months or 12 months) and 24 months.