Ignite Creation Date:
2025-12-24 @ 1:13 PM
Ignite Modification Date:
2026-01-28 @ 12:51 AM
Study NCT ID:
NCT01759095
Status:
TERMINATED
Last Update Posted:
2015-04-09
First Post:
2012-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidrug Blister Pack Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Difficulties with patient recruitement', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2012-11-02', 'studyFirstSubmitQcDate': '2012-12-23', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to rehospitalisation + time to major therapy adjustment', 'timeFrame': '12 months', 'description': 'The outcome measure will be assessed at 3, 6, and 12 months.'}, {'measure': 'Medication Possession Ratio', 'timeFrame': '12 months', 'description': 'MPR will be assessed at 3, 6, and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Timing and taking adherence according to the electronic monitoring system and through patient self report', 'timeFrame': '12 months', 'description': 'Electronic monitoring will be continuous over 12 months. Patient self report will be assessed at 3, 6, and 12 months.'}, {'measure': 'Quality of life', 'timeFrame': '12 months', 'description': 'Quality of life will be assessed at 3, 6, and 12 months.'}, {'measure': 'Patient satisfaction', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adherence', 'electronic monitoring', 'primary care', 'community pharmacy', 'multidrug blister pack', 'pill box'], 'conditions': ['Any Event Leading to Hospitalisation']}, 'referencesModule': {'references': [{'pmid': '21901694', 'type': 'BACKGROUND', 'citation': 'Mahtani KR, Heneghan CJ, Glasziou PP, Perera R. Reminder packaging for improving adherence to self-administered long-term medications. Cochrane Database Syst Rev. 2011 Sep 7;(9):CD005025. doi: 10.1002/14651858.CD005025.pub3.'}, {'pmid': '9467683', 'type': 'BACKGROUND', 'citation': 'Cramer JA. Enhancing patient compliance in the elderly. Role of packaging aids and monitoring. Drugs Aging. 1998 Jan;12(1):7-15. doi: 10.2165/00002512-199812010-00002.'}, {'pmid': '16079372', 'type': 'BACKGROUND', 'citation': 'Osterberg L, Blaschke T. Adherence to medication. N Engl J Med. 2005 Aug 4;353(5):487-97. doi: 10.1056/NEJMra050100. No abstract available.'}, {'pmid': '14998735', 'type': 'BACKGROUND', 'citation': 'Rosen MI, Rigsby MO, Salahi JT, Ryan CE, Cramer JA. Electronic monitoring and counseling to improve medication adherence. Behav Res Ther. 2004 Apr;42(4):409-22. doi: 10.1016/S0005-7967(03)00149-9.'}], 'seeAlsoLinks': [{'url': 'http://www.pharmacare.unibas.ch', 'label': 'Pharmaceutical Care Research Group, University of Basel, Switzerland'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the benefit of patients using a multidrug blister packs after discharged from an university hospital to their homes.', 'detailedDescription': 'Typical adherence rates for oral prescription medications are approximately 50-76%. Insufficient adherence causes an increase in morbidity, mortality, and costs, and decreases quality of life of patients. Multidrug blister packs are recommended to improve adherence and are widely used in Switzerland. However, evidence is poor and patient-relevant endpoints are seldom measured. This study was designed to compare patient-relevant outcomes in patients with medication repackaged in multidrug blister packs versus patients with medication dispensed in commercially available packages. Adherence of the intervention group will be monitored electronically and feedback will be given to the patients. The intervention will take place in a study pharmacy. Follow-up visits will take place at the study pharmacy at 3, 6, and 12 months for all patients. Study duration will be 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Prescription of 4 or more different oral solid drugs\n* Capable to understand german (verbally and written)\n* Capable to give informed consent\n* Insured by a Swiss health insurance\n* Manages his/her pharmacotherapy without external support\n* Obtains his/her medication from a community pharmacy\n* Accepts to use an electronic multidrug blister pack\n* Place of domicile in Basel-Stadt or Basel-Land\n\nExclusion Criteria:\n\n* Pregnancy\n* \\> 2 drugs that cannot be packed into a multidrug blister pack (e.g. fluids)\n* Dementia, or evaluated as cognitively impaired by the responsible nurse\n* Transplanted patient\n* Anticoagulation with oral vitamin K antagonists\n* Has already used a multidrug blister pack of Pharmis or a Medifilm® single dose system\n* is visually impaired (blind)\n* cannot push drugs through a blister\n* refuses to allow contact to his/her regular pharmacy and GP\n* is referred to a nursing home or to rehabilitation or another hospital at discharge\n* is included in other clinical trial'}, 'identificationModule': {'nctId': 'NCT01759095', 'briefTitle': 'Multidrug Blister Pack Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Electronic Multidrug Blister Packs to Improve Clinical and Humanistic Outcomes in Patients After Hospital Discharge', 'orgStudyIdInfo': {'id': 'EKBB54/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'At hospital discharge, patients of the control group will receive usual care at their community pharmacy.'}, {'type': 'EXPERIMENTAL', 'label': 'Electronic Multidrug Blister Pack', 'interventionNames': ['Device: Electronic multidrug blister pack']}], 'interventions': [{'name': 'Electronic multidrug blister pack', 'type': 'DEVICE', 'otherNames': ['Multidrug blister pack: Pharmis GmbH, Beinwil am See, Switzerland', 'Electronic film: Confrérie Clinique S.A., Lausanne, Switzerland'], 'description': 'At hospital discharge, patients will get their prescribed drugs repackaged in an electronic multidrug blister pack with 7x4 cavities. The electronic film affixed on the rear side measures the date and time when a loop is broken, i.e. when a cavity is emptied. Patients will get feedback on their adherence profiles at the community pharmacy.', 'armGroupLabels': ['Electronic Multidrug Blister Pack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4056', 'city': 'Basel', 'state': 'Canton of Basel-City', 'country': 'Switzerland', 'facility': 'Notfallapotheke', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Kurt E Hersberger, Prof PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Basel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kurt Hersberger', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor PhD', 'investigatorFullName': 'Kurt Hersberger', 'investigatorAffiliation': 'University Hospital, Basel, Switzerland'}}}}