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

Not Applicable

Completed

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

• Registration Number: NCT04190251
• Lead Sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2016-04-14
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-12-04
• Study First Posted: 2019-12-09
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Medication adherence (longitudinal data)	24 months	Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months)

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction	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.	In depths and semi-structured interviews to assess patient's opinions about the program
Medication adherence	6 months or 12 months post-intervention phase	Number of patients with an electronic medication adherence ≤ 30% for at least one medication throughout two successive pharmacy visits during the post-intervention phase
Clinical outcomes	Baseline, 6 monts and 12 months post-intervention	UKPDS score

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Vaud, Switzerland

Unisante; 🇨🇭 Lausanne, Vaud, Switzerland