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Diabetes Mellitus, Type 2PANDIA_IRISNCT04190251

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

A study testing Inteprofessional medication adherence support program (IMAP) in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 2 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Inteprofessional medication adherence support program (IMAP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
2 sitesSwitzerland
Study dates
14 Apr 2016to 20 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Switzerland2 sites

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, Canton of Vaud, 1011

  • Unisante

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

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.

Read the 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).

Being tested
Inteprofessional medication adherence support program (IMAP)
Keywords
Medication adherence, Diabetes Mellitus, Renal Insufficiency, Chronic, Interprofessional Relations
Medical subject headings
Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Medication Adherence, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04190251
Study groupRoleWhat they receive
Intervention group AOtherIntervention 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
Receives: Other: Inteprofessional medication adherence support program (IMAP)
Intervention group BOtherIntervention 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
Receives: Other: Inteprofessional medication adherence support program (IMAP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24 months

Secondary outcomes (4)

  1. Clinical outcomes

    ADVANCE kidney score

    Measured: Baseline, 6 monts and 12 months post-intervention

  2. Clinical outcomes

    UKPDS score

    Measured: Baseline, 6 monts and 12 months post-intervention

  3. 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

    Measured: 6 months or 12 months post-intervention phase

  4. Patients' satisfaction

    In depths and semi-structured interviews to assess patient's opinions about the program

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2019
  2. Study start14 Apr 2016
  3. Primary completion20 Dec 2022
  4. Study completion20 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04190251
Sponsor's protocol ID
PB_2016-01674(454/15)
Acronym
PANDIA_IRIS
Status last verified
Jul 2026
First submitted
22 Oct 2019
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 38327981

  • 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.

    PubMed 36167584

  • 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.

    PubMed 33739292

Questions about this trial

What is this clinical trial studying?

A study testing Inteprofessional medication adherence support program (IMAP) in people with Diabetes Mellitus, Type 2 and Renal Insufficiency, Chronic, run by Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland at 2 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication adherence (longitudinal data) (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04190251, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.

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