Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03321058
Status:
COMPLETED
Last Update Posted:
2017-10-25
First Post:
2017-06-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-06-01', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Insight in patients' organisation of polymedication", 'timeFrame': 'retrospective 3 months', 'description': "Patients organise their multiple medications differently in daily life. The study will investigate the different organisation strategies to get a better understanding of patients' behaviour. The behaviour is assessed with a questionnaire containing 14 questions on the management of medication including single choice, multiple choice and free text questions. As example the number of patients already using a medication organisation system will be assessed, the number of patients using a weekly or daily pillbox will be assessed, and who is filling the medication organisation system."}, {'measure': "Insight in patients' comprehension of generics", 'timeFrame': 'retrospective 3 months', 'description': "Patients have a different comprehension of generics including their advantages and disadvantages. The study will investigate patients' comprehension of generics to get a better understanding of patients' behaviour. The comprehension is assessed with a questionnaire containing 4 questions on the believes about generics including single choice, multiple choice and free text questions. As example the number of patients knowing that they use generics is assessed and the patient's personal opinion on advantages and disadvantages of generics is investigated."}], 'secondaryOutcomes': [{'measure': 'Number of patients using Multicompartment Compliance Aids.', 'timeFrame': 'retrospective 3 months', 'description': 'Assessment of proportion of patients already using Multicompartment Compliance Aids prior to interview.'}, {'measure': 'Number of substitutable medicines.', 'timeFrame': 'retrospective 3 months', 'description': 'Assessment of number of brand name medication which could be substituted by generic medication and willingness of pharmacists to recommend generic medicines.'}, {'measure': 'Swallowing difficulties', 'timeFrame': 'retrospective 3 months', 'description': 'Prevalence of present and/or past swallowing difficulties and coping strategies will be assessed. A specific question (from SWAMECO) on the experienced swallowing difficulties is asked and will be answered on a visual analog scale (0 to 100%). If swallowing-difficulties are present, 2 more questions are asked: Which medication is difficult to swallow and how medication is altered in order to be able to swallow them.'}, {'measure': 'Recommended use of Multicompartment Compliance Aids', 'timeFrame': 'retrospective 3 months', 'description': 'Number of recommended use of Multicompartment Compliance Aids by pharmacists.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Substitution', 'Multicompartment Compliance Aid'], 'conditions': ['Medication Therapy Management', 'Medication Adherence']}, 'referencesModule': {'references': [{'pmid': '27108410', 'type': 'BACKGROUND', 'citation': 'Messerli M, Blozik E, Vriends N, Hersberger KE. Impact of a community pharmacist-led medication review on medicines use in patients on polypharmacy--a prospective randomised controlled trial. BMC Health Serv Res. 2016 Apr 23;16:145. doi: 10.1186/s12913-016-1384-8.'}, {'pmid': '23134096', 'type': 'BACKGROUND', 'citation': "Olsson E, Kalvemark Sporrong S. Pharmacists' experiences and attitudes regarding generic drugs and generic substitution: two sides of the coin. Int J Pharm Pract. 2012 Dec;20(6):377-83. doi: 10.1111/j.2042-7174.2012.00214.x. Epub 2012 Jun 1."}, {'pmid': '19708764', 'type': 'BACKGROUND', 'citation': 'Hakonsen H, Eilertsen M, Borge H, Toverud EL. Generic substitution: additional challenge for adherence in hypertensive patients? Curr Med Res Opin. 2009 Oct;25(10):2515-21. doi: 10.1185/03007990903192223.'}, {'pmid': '21542662', 'type': 'BACKGROUND', 'citation': 'Nunney J, Raynor DK, Knapp P, Closs SJ. How do the attitudes and beliefs of older people and healthcare professionals impact on the use of multi-compartment compliance aids?: a qualitative study using grounded theory. Drugs Aging. 2011 May 1;28(5):403-14. doi: 10.2165/11587180-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': "Patients using multiple drugs including generics have found different solutions to manage their medication. During a Polymedication-Check (medication review type 2a service in community pharmacies) additional information about the organisation of patients' medication in daily life will be compiled in Swiss community pharmacies. Data will allow to better address patients' needs in their medication organisation and comprehension of generics."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population comprises adults (18 years and older) with at least 4 prescribed medicines which they are taking for at least 3 months. One of those medicines must be a generic drug, one must be prescribed for a cardiovascular condition (ATC C01-10). Patients cannot have their medication provided in a Multicompartment Compliance Aid or a similar device by a specific service like home care, pharmacy or home for elderly.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 4 medicines for at least 3 months\n* at least 1 generic drug\n* at least 1 medicine of ATC code cardiovascular system (C01-10)\n\nExclusion Criteria:\n\n* medication provided in Multicompartment Compliance Aid or similar device by specific service (pharmacy, elderly home, home care)'}, 'identificationModule': {'nctId': 'NCT03321058', 'briefTitle': "Polymedication-Check With Insight in Patients' Medication Organisation and Comprehension of Generics", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Polymedikations-Check Und Medikamenten-Organisation im Alltag', 'orgStudyIdInfo': {'id': 'PMC-Medication-Organisation'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Assessment', 'type': 'BEHAVIORAL', 'description': "Assessment of patients' medication organisation and comprehension of generics"}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'University of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Kurt Hersberger', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}