Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-09 @ 5:39 AM
Study NCT ID:
NCT04190251
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2019-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2019-12-04', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Medication adherence (longitudinal data)', 'timeFrame': '24 months', 'description': 'Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months)'}], 'secondaryOutcomes': [{'measure': 'Clinical outcomes', 'timeFrame': 'Baseline, 6 monts and 12 months post-intervention', 'description': 'ADVANCE kidney score'}, {'measure': 'Clinical outcomes', 'timeFrame': 'Baseline, 6 monts and 12 months post-intervention', 'description': 'UKPDS score'}, {'measure': 'Medication adherence', 'timeFrame': '6 months or 12 months post-intervention phase', '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'}, {'measure': "Patients' satisfaction", 'timeFrame': '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.', 'description': "In depths and semi-structured interviews to assess patient's opinions about the program"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication adherence', 'Diabetes Mellitus', 'Renal Insufficiency, Chronic', 'Interprofessional Relations'], 'conditions': ['Diabetes Mellitus, Type 2', 'Renal Insufficiency, Chronic']}, 'referencesModule': {'references': [{'pmid': '38327981', 'type': 'DERIVED', 'citation': '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': '36167584', 'type': 'DERIVED', '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.'}, {'pmid': '33739292', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe medication adherence data will be analysed in both groups along with clinical data obtained through draw samples regularly prescribed by the physician.\n\n\\*Since the 1st January 2019, the Policlinique Médicale Universitaire became Unisanté, University Center for Primary Care and Public Health (Lausanne, Switzerland)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* MDRD or CKD-EPI eGFR ≤60 ml/min/1.73m2 or albumin/creatinin \\>30mg/mmol\n* Type 2 diabetes\n* At least one medication in the following list : oral antidiabetics and/or statins and/or antihypertensive drugs and/or aspirin\n* Patients speaking french, english or italian or interpreter present at each pharmacy visit\n* Patients have to sign the written consent form\n* Patients have to agree to use the Electronic Monitoring system (EM, named MEMS®; Aardex Ltd)\n* Complete laboratory exams in the last 6 months: eGFR and HbA1c and (albumin/creatinin ratio or total cholesterol + LDL + HDL)\n\nExclusion Criteria:\n\n* Not being able to understand or sign the consent form\n* Pregnancy\n* Recent cancer diagnosis\n* Cognitive disorder\n* The subject does not manage the treatment alone'}, 'identificationModule': {'nctId': 'NCT04190251', 'acronym': 'PANDIA_IRIS', 'briefTitle': 'PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program', 'organization': {'class': 'OTHER', 'fullName': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, 'officialTitle': 'PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program', 'orgStudyIdInfo': {'id': 'PB_2016-01674(454/15)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention group A', '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", 'interventionNames': ['Other: Inteprofessional medication adherence support program (IMAP)']}, {'type': 'OTHER', 'label': 'Intervention group B', '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", 'interventionNames': ['Other: Inteprofessional medication adherence support program (IMAP)']}], 'interventions': [{'name': 'Inteprofessional medication adherence support program (IMAP)', 'type': 'OTHER', '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.", 'armGroupLabels': ['Intervention group A', 'Intervention group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Centre Hospitalier Universitaire Vaudois', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}, {'zip': '1011', 'city': 'Lausanne', 'state': 'Canton of Vaud', 'country': 'Switzerland', 'facility': 'Unisante', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Marie-Paule Schneider, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, {'name': 'Carole Bandiera, PhD student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}, {'name': 'Anne Zanchi, PhD-PD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHUV (Centre hospitalier Universitaire Vaudois)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'pharmaSuisse', 'class': 'UNKNOWN'}, {'name': 'santésuisse', 'class': 'UNKNOWN'}, {'name': 'Curafutura', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pr. Schneider Marie P., PhD', 'investigatorFullName': 'Marie Schneider', 'investigatorAffiliation': 'Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland'}}}}