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

Primary Purpose

Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Inteprofessional medication adherence support program (IMAP)
Sponsored by
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Medication adherence, Diabetes Mellitus, Renal Insufficiency, Chronic, Interprofessional Relations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire Vaudois
  • Unisante

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Intervention group A

Intervention group B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Clinical outcomes
ADVANCE kidney score
Clinical outcomes
UKPDS score
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
Patients' satisfaction
In depths and semi-structured interviews to assess patient's opinions about the program

Full Information

First Posted
October 22, 2019
Last Updated
February 22, 2023
Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
pharmaSuisse, santésuisse, Curafutura
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1. Study Identification

Unique Protocol Identification Number
NCT04190251
Brief Title
PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Acronym
PANDIA_IRIS
Official Title
PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2016 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Collaborators
pharmaSuisse, santésuisse, Curafutura

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
Keywords
Medication adherence, Diabetes Mellitus, Renal Insufficiency, Chronic, Interprofessional Relations

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group A
Arm Type
Other
Arm Description
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
Arm Title
Intervention group B
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Inteprofessional medication adherence support program (IMAP)
Intervention Description
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 Outcome Measure Information:
Title
Medication adherence (longitudinal data)
Description
Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months)
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Clinical outcomes
Description
ADVANCE kidney score
Time Frame
Baseline, 6 monts and 12 months post-intervention
Title
Clinical outcomes
Description
UKPDS score
Time Frame
Baseline, 6 monts and 12 months post-intervention
Title
Medication adherence
Description
Number of patients with an electronic medication adherence ≤ 30% for at least one medication throughout two successive pharmacy visits during the post-intervention phase
Time Frame
6 months or 12 months post-intervention phase
Title
Patients' satisfaction
Description
In depths and semi-structured interviews to assess patient's opinions about the program
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Paule Schneider, Prof.
Organizational Affiliation
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carole Bandiera, PhD student
Organizational Affiliation
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne Zanchi, PhD-PD
Organizational Affiliation
CHUV (Centre hospitalier Universitaire Vaudois)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire Vaudois
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Unisante
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
1011
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
36167584
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.
Results Reference
derived
PubMed Identifier
33739292
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.
Results Reference
derived

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

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