Ignite Creation Date:
2025-12-24 @ 4:34 PM
Ignite Modification Date:
2025-12-26 @ 2:39 PM
Study NCT ID:
NCT04772066
Status:
UNKNOWN
Last Update Posted:
2021-03-08
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tools to Assess Medication Adherence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055118', 'term': 'Medication Adherence'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-03-05', 'studyFirstSubmitDate': '2021-02-23', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-reported MA according to self-reported medication adherence scale', 'timeFrame': '1 day', 'description': 'Self-reported MA according to self-reported MA scale : The self-report scale ranges from 0 (low) to 10 (high adherence)'}, {'measure': 'MA according to Medication Possession Ratio (MPR) calculation', 'timeFrame': '1 day', 'description': 'MA according to Medication Possession Ratio (MPR) calculation'}], 'secondaryOutcomes': [{'measure': 'Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation', 'timeFrame': '1 day', 'description': 'Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation'}, {'measure': 'Variables associated with medication non-adherence', 'timeFrame': '1 day', 'description': 'Variables associated with medication non-adherence'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Medication Adherence', 'Clinical Pharmacist', 'Self-reported scale'], 'conditions': ['Medication Adherence']}, 'descriptionModule': {'briefSummary': "The issue of medication adherence (MA) has long been undestimated but is now growing interest due to both the increase of patients with chronic diseases and the aging of the population. According to the World Health Organization, only 50% of patients with chronic illnesses correctly follow physician's prescriptions in developed countries. Beyond the individual consequences that failure to adherence can engender (increased morbidity, mortality and hospitalizations), this concept also encompasses a collective dimension (risk of transmission of infectious diseases and increased health care costs). Today, improving MA would have more impact on human health than developping new medical therapies. That's why detecting non-adherence constitutes a major public health issue in which pharmacists play a significant role through medication reconciliation and patients' education.\n\nThe methods wildly used are based on indirect measurement: questionnaires completed by the patient himself or the Medication Possession Ratio (MPR). Each method has its own advantages and disadvantages, but none is considered as the gold standard. The Montpellier University Hospital set up a MA self-report scale ranging from 0 (low) to 10 (high adherence) in the various care units where the clinical pharmacy activity is deployed.\n\nThe purpose of this study was to assess the MA according to this numerical scale and the MPR calculation, and evaluate the correlation between these two methods."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Study population was composed of patients admitted in Montpellier University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed\n\nExclusion criteria:\n\n\\- Subjects without any medication therapy at home'}, 'identificationModule': {'nctId': 'NCT04772066', 'briefTitle': 'Tools to Assess Medication Adherence', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Evaluation of Tools to Assess Medication Adherence', 'orgStudyIdInfo': {'id': 'RECHMPL20_0662'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non adherent patients', 'description': 'Non adherent patients', 'interventionNames': ['Other: Measure of medication adherence']}, {'label': 'Adherent patients', 'description': 'Adherent patients', 'interventionNames': ['Other: Measure of medication adherence']}], 'interventions': [{'name': 'Measure of medication adherence', 'type': 'OTHER', 'description': 'Measure of medication adherence', 'armGroupLabels': ['Adherent patients', 'Non adherent patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'cyril BREUKER', 'role': 'CONTACT', 'email': 'c-breuker@chu-montpellier.fr'}, {'name': 'Laura Lohan-Descamps', 'role': 'CONTACT'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Cyril BREUKER, PharmD,Phd', 'role': 'CONTACT', 'email': 'c-breuker@chu-montpellier.fr', 'phone': '467337121', 'phoneExt': '33'}, {'name': 'Laura Lohan-Descamps, PharmD', 'role': 'CONTACT', 'email': 'lohan_descamps@chu-montpellier.fr', 'phone': '467338562', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Cyril BREUKER, PharmD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}