Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT02701660
Status:
COMPLETED
Last Update Posted:
2018-04-18
First Post:
2014-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2014-11-25', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Taking Adherence (Number of days with correctly dispensed pouches (%)', 'timeFrame': 'continuous, up to 24 weeks', 'description': 'Number of days with correctly dispensed pouches (%)'}], 'secondaryOutcomes': [{'measure': 'Timing adherence (number of correctly dispensed pouches within predefined time-frame (%)', 'timeFrame': 'continuous, up to 24 weeks', 'description': 'number of correctly dispensed pouches within predefined time-frame (%)'}, {'measure': "Patients' specific routine parameters according to condition(s) of participant (composite outcome)", 'timeFrame': 'up to 24 weeks', 'description': 'Individual clinical outcomes, eg blood pressure, blood sugar, HIV count...'}, {'measure': 'Psychological distress', 'timeFrame': 'inclusion, week 12, 24, 36', 'description': 'SCL-90R self-report questionnaire'}, {'measure': 'Quality of Life', 'timeFrame': 'inclusion, weeks 3, 6, 9, 12, 15, 18, 21, 24, 36', 'description': 'SF-12 self-report questionnaire'}, {'measure': 'Satisfaction', 'timeFrame': 'week 12, 24, 36', 'description': 'self-report questionnaire, interview'}, {'measure': 'Instrumental Activities of Daily Living', 'timeFrame': 'inclusion, week 12, 24, 36', 'description': 'Instrumental Activities of Daily Living Scale (Lawton-Brody)'}, {'measure': 'Cognitive Impairment', 'timeFrame': 'inclusion, week 12, 24, 36', 'description': 'Montreal Cognitive Assessment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmaceutical Care', 'Adherence', 'Polypharmacy', 'e-Health', 'opioid substitution therapy'], 'conditions': ['Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'Electronic dispensers for polypharmacy are used in home care to assist patients with their medication management and to improve adherence. Opioid dependent patients with substitution therapy often exhibit multiple risk factors for non-adherence. The increase of both the age and associated comorbidities in this population demand for innovative solutions to optimize medication management. The investigators developed a novel medication supply model with an automated electronic medication dispenser to simultaneously assist opioid dependent patients with their medication and objectively monitor their adherence. This study aims to demonstrate the feasibility of the new supply model.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent given\n* reading and writing skills in German\n* Stable housing situation in the canton of Basel-City and adjacent communities\n* Accessibility by phone\n* Minimum duration in opioid substitution treatment for 2 months\n* Polypharmacy (\\> 3 solid oral medications)\n* Routine monitoring of clinical parameters less than 1 week before inclusion or agreed within 1 week from inclusion\n* Insured with Swiss health insurance\n\nExclusion Criteria:\n\n* opioid substitution treatment with Diacetylmorphine\n* \\> 2 drugs, which can not be packaged in pouches (eg liquids)'}, 'identificationModule': {'nctId': 'NCT02701660', 'acronym': 'APPOSTEL', 'briefTitle': 'Adherence to Polypharmacy in Patients With Opioid Substitution Therapy Using Electronics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Remote-controlled Dispensing of Medication and Electronic Monitoring of Adherence in Ambulatory Patients With Opioid Dependency Syndrome and Polypharmacy - a Feasibility Trial', 'orgStudyIdInfo': {'id': 'APPOSTEL-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'electronic medication dispenser', 'description': 'An Automatic Tablet Dispensing and Packaging System is used to repack all solid oral prescription medications for each participant into unit-of-dose pouches. Every participant receives a roll with pouches for 14-28 days loaded into a dispenser installed at their homes. The electronic medication dispenser is a remote controlled, electronic medication management aid reminding the patients with acoustic alerts to take their medication.', 'interventionNames': ['Device: electronic medication dispenser (medido)']}], 'interventions': [{'name': 'electronic medication dispenser (medido)', 'type': 'DEVICE', 'otherNames': ['medido'], 'description': 'Automated dispense of medication through an electronic dispenser', 'armGroupLabels': ['electronic medication dispenser']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Outpatient addiction service, University Psychiatric Clinics', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Kurt Hersberger, Prof. MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Basel', 'class': 'OTHER'}, {'name': 'Psychiatric Hospital of the University of Basel', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}