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

University Center for Primary Care and Public Health (Unisanté)

Status: Completed

Conditions: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Treatments: Other: Inteprofessional medication adherence support program (IMAP)

Study type: Interventional

Funder types: Other

Identifiers

NCT04190251

PB_2016-01674(454/15)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Intervention group A

Other group

Description:

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

Treatment:

Other: Inteprofessional medication adherence support program (IMAP)

Intervention group B

Other group

Description:

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

Treatment:

Other: Inteprofessional medication adherence support program (IMAP)