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Completed

NCT Number: NCT04190251

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Behavior Chronic Disease Diabetes Mellitus Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Health Behavior Kidney Diseases Male Urogenital Diseases Medication Adherence Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Renal Insufficiency Renal Insufficiency, Chronic Treatment Adherence and Compliance Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire Vaudois, Lausanne, Canton of Vaud, Switzerland

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inteprofessional medication adherence support program (IMAP)

Other

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.

Primary outcomes

  1. Medication adherence (longitudinal data)

    Time frame: 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 outcomes

  1. Clinical outcomes

    Time frame: Baseline, 6 monts and 12 months post-intervention

    ADVANCE kidney score

  2. Clinical outcomes

    Time frame: Baseline, 6 monts and 12 months post-intervention

    UKPDS score

  3. Medication adherence

    Time frame: 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

  4. Patients' satisfaction

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland

Other

Collaborators

  • Curafutura
  • pharmaSuisse
  • santésuisse

Registry information

Acronym: PANDIA_IRIS

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2019
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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