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

Diabetes Mellitus, Type 2 Clinical Trial

— PANDIA_IRIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190251
• Other study ID #: PB_2016-01674(454/15)
• Status: Completed
• Phase: N/A
• Start date: April 14, 2016
• Est. completion date: December 20, 2022

Study information

• Verified date: February 2023
• Source: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Other:
• Inteprofessional medication adherence support program (IMAP)
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.

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	Vaud
Switzerland	Unisante	Lausanne	Vaud

Sponsors (4)

Lead Sponsor	Collaborator
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	Curafutura, pharmaSuisse, santésuisse

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Clinical outcomes	ADVANCE kidney score	Baseline, 6 monts and 12 months post-intervention
Secondary	Clinical outcomes	UKPDS score	Baseline, 6 monts and 12 months post-intervention
Secondary	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
Secondary	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.