Clinical trial NCT04190251: PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Official title: PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Renal Insufficiency, Chronic
Keywords: Medication adherence
Diabetes Mellitus
Renal Insufficiency, Chronic
Interprofessional Relations
Lead sponsor: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Sponsor class: OTHER
Collaborators: name: pharmaSuisse
name: santésuisse
name: Curafutura
First posted: 2019-12-09
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Medication adherence (longitudinal data)
timeFrame: 24 months
Secondary outcomes:
measure: Clinical outcomes
timeFrame: Baseline, 6 monts and 12 months post-intervention
measure: Clinical outcomes
timeFrame: Baseline, 6 monts and 12 months post-intervention
measure: Medication adherence
timeFrame: 6 months or 12 months post-intervention phase
measure: Patients' satisfaction
timeFrame: 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.
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
city: Lausanne
country: Switzerland
facility: Unisante
state: Vaud
Study officials:
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Marie-Paule Schneider, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
name: Carole Bandiera, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV (Centre hospitalier Universitaire Vaudois)
name: Anne Zanchi, PhD-PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bandiera C, Lam L, Locatelli I, Dotta-Celio J, Duarte D, Wuerzner G, Pruijm M, Zanchi A, Schneider MP. Understanding reasons and factors for participation and non-participation to a medication adherence program for patients with diabetic kidney disease in Switzerland: a mixed methods study. Diabetol Metab Syndr. 2022 Sep 27;14(1):140. doi: 10.1186/s13098-022-00898-7.
citation: Bandiera C, Dotta-Celio J, Locatelli I, Nobre D, Wuerzner G, Pruijm M, Lamine F, Burnier M, Zanchi A, Schneider MP. Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS). JMIR Res Protoc. 2021 Mar 19;10(3):e25966. doi: 10.2196/25966.