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

NCT04190251 | Completed DMC

• 1 other identifier: PB_2016-01674(454/15)
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Keywords

Medication adherence; Diabetes Mellitus; Renal Insufficiency, Chronic; Interprofessional Relations

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Clinical outcomes

  Baseline, 6 monts and 12 months post-intervention

• Clinical outcomes

  Baseline, 6 monts and 12 months post-intervention

• Medication adherence

  6 months or 12 months post-intervention phase

• 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.

Study Arms (2)

Intervention group A

OTHER

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)

Intervention group B

OTHER

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)

Interventions

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.

Intervention group A; Intervention group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Not being able to understand or sign the consent form
• Pregnancy
• Recent cancer diagnosis
• Cognitive disorder
• The subject does not manage the treatment alone

Sponsors & Collaborators

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

Study Sites (2)

Centre Hospitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Unisante

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (3)

• Bandiera C, Dotta-Celio J, Locatelli I, Nobre D, Wuerzner G, Pruijm M, Lamine F, Burnier M, Zanchi A, Schneider MP. The differential impact of a 6-versus 12-month pharmacist-led interprofessional medication adherence program on medication adherence in patients with diabetic kidney disease: the randomized PANDIA-IRIS study. Front Pharmacol. 2024 Jan 24;15:1294436. doi: 10.3389/fphar.2024.1294436. eCollection 2024.

  PMID: 38327981 DERIVED

• 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.

  PMID: 36167584 DERIVED

• 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.

  PMID: 33739292 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic; Medication Adherence; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pr. Schneider Marie P., PhD

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: December 9, 2019
• Study Start: April 14, 2016
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

CH (2)