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

Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland (Other)
Overall Status
Recruiting
CT.gov ID
NCT04190251
Collaborator
pharmaSuisse (Other), santésuisse (Other), Curafutura (Other)
70
Enrollment
2
Locations
2
Arms
80.6
Anticipated Duration (Months)
35
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Inteprofessional medication adherence support program (IMAP)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Actual Study Start Date :
Apr 14, 2016
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: Intervention group A

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

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.
Other: Intervention group B

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

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Clinical outcomes [Baseline, 6 monts and 12 months post-intervention]

    ADVANCE kidney score

  2. Clinical outcomes [Baseline, 6 monts and 12 months post-intervention]

    UKPDS score

  3. 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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire Vaudois Lausanne Vaud Switzerland 1011
2 Unisante Lausanne Vaud Switzerland 1011

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Marie-Paule Schneider, Prof., Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
  • Principal Investigator: Carole Bandiera, PhD student, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
  • Principal Investigator: Anne Zanchi, PhD-PD, CHUV (Centre hospitalier Universitaire Vaudois)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marie Schneider, Pr. Schneider Marie P., PhD, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
ClinicalTrials.gov Identifier:
NCT04190251
Other Study ID Numbers:
  • PB_2016-01674(454/15)
First Posted:
Dec 9, 2019
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Marie Schneider, Pr. Schneider Marie P., PhD, Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Medication adherence
Diabetes Mellitus
Renal Insufficiency, Chronic
Interprofessional Relations
Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 23, 2022