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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

Conditions
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Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

Intervention / Treatment
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* Other: Inteprofessional medication adherence support program (IMAP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intervention group A<br>Intervention group A will benefit of the medication adherence support program during 12 months. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visits, the pharmacist will conduct an 15 minutes, semi-structured interview based on Fisher's sociocognitiv model with the patients. A summary and the adherence graph will be send to all the involved health professionals | Other: Inteprofessional medication adherence support program (IMAP)<br>* 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.<br>|
| Other: Intervention group B<br>Intervention group A will benefit of the medication adherence support program during 6 months. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visits, the pharmacist will conduct an 15 minutes, semi-structured interview based on Fisher's sociocognitiv model with the patients. A summary and the adherence graph will be send to all the involved health professionals | Other: Inteprofessional medication adherence support program (IMAP)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcomes | ADVANCE kidney score | Baseline, 6 monts and 12 months post-intervention | 
| Clinical outcomes | UKPDS score | 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 | 6 months or 12 months post-intervention phase | 
| Patients' satisfaction | In depths and semi-structured interviews to assess patient's opinions about the program | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medication adherence, Diabetes Mellitus, Renal Insufficiency, Chronic, Interprofessional Relations