Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT00794560
Status:
COMPLETED
Last Update Posted:
2014-11-18
First Post:
2008-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-management of Low Molecular Weight Heparin Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'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': 'D010353', 'term': 'Patient Education as Topic'}], 'ancestors': [{'id': 'D006266', 'term': 'Health Education'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'seraina.mengiardi@unibas.ch', 'phone': '061 267 15 29', 'title': 'Dr. Seraina Mengiardi', 'phoneExt': '0041', 'organization': 'Pharmaceutical Care Research Group, University of Basle, Switzerland'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'During the entire individual s.c. injection therapy, up to 6 weeks.', 'description': 'Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).', 'eventGroups': [{'id': 'EG000', 'title': 'Clinical Setting: Intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist", 'otherNumAtRisk': 36, 'otherNumAffected': 33, 'seriousNumAtRisk': 36, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Clinical Setting: Standard Care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)', 'otherNumAtRisk': 36, 'otherNumAffected': 29, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Daily Life Setting: Intervention', 'description': "Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist", 'otherNumAtRisk': 44, 'otherNumAffected': 37, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Daily Life Setting: Standard Care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)', 'otherNumAtRisk': 38, 'otherNumAffected': 17, 'seriousNumAtRisk': 38, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hematoma at injection site', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 31, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 26, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 35, 'numAffected': 35}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'mild injection site irritation/burning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 17, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 22, 'numAffected': 22}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'hematoma in general', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'induration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'exanthema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Allergy / hypersensitivity', 'notes': 'hospitalisation due to allergy, completely recovered', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 44, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Drug Use Problems', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Setting: Intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'OG001', 'title': 'Clinical Setting: Standard Care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)'}, {'id': 'OG002', 'title': 'Daily Life Setting: Intervention', 'description': "Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'OG003', 'title': 'Daily Life Setting: Standard Care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.25', 'spread': '0.27', 'groupId': 'OG000'}, {'value': '0.86', 'spread': '0.33', 'groupId': 'OG001'}, {'value': '1.20', 'spread': '0.41', 'groupId': 'OG002'}, {'value': '1.17', 'spread': '0.40', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'during the individual drug therapy, an average of 18 days', 'description': 'During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Clinical Setting: Intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'OG001', 'title': 'Clinical Setting: Standard Care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)'}, {'id': 'OG002', 'title': 'Daily Life Setting: Intervention', 'description': "Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'OG003', 'title': 'Daily Life Setting: Standard Care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)'}], 'classes': [{'categories': [{'measurements': [{'value': '94.5', 'spread': '10.5', 'groupId': 'OG000'}, {'value': '96.2', 'spread': '10.6', 'groupId': 'OG001'}, {'value': '95.1', 'spread': '10.0', 'groupId': 'OG002'}, {'value': '97.5', 'spread': '4.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at the end of the individual drug therapy, an average of 18 days', 'description': 'objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).', 'unitOfMeasure': 'percentage of syringes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction', 'timeFrame': 'at the end of the individual drug therapy, an average of 18 days', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Clinical Setting: Intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'FG001', 'title': 'Clinical Setting: Standard Care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)'}, {'id': 'FG002', 'title': 'Daily Life Setting: Intervention', 'description': "Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'FG003', 'title': 'Daily Life Setting: Standard Care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}, {'groupId': 'FG002', 'numSubjects': '44'}, {'groupId': 'FG003', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '40'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '139', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Clinical Setting: Intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'BG001', 'title': 'Clinical Setting: Standard Care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)'}, {'id': 'BG002', 'title': 'Daily Life Setting: Intervention', 'description': "Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\npatient education: Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist"}, {'id': 'BG003', 'title': 'Daily Life Setting: Standard Care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '34', 'upperLimit': '60'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '42', 'upperLimit': '66'}, {'value': '51', 'groupId': 'BG002', 'lowerLimit': '36', 'upperLimit': '65'}, {'value': '54', 'groupId': 'BG003', 'lowerLimit': '43', 'upperLimit': '67'}, {'value': '54', 'groupId': 'BG004', 'lowerLimit': '40', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '69', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 154}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-05', 'studyFirstSubmitDate': '2008-11-18', 'resultsFirstSubmitDate': '2014-06-04', 'studyFirstSubmitQcDate': '2008-11-19', 'lastUpdatePostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-23', 'studyFirstPostDateStruct': {'date': '2008-11-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drug Use Problems', 'timeFrame': 'during the individual drug therapy, an average of 18 days', 'description': 'During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.'}], 'secondaryOutcomes': [{'measure': 'Compliance', 'timeFrame': 'at the end of the individual drug therapy, an average of 18 days', 'description': 'objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'at the end of the individual drug therapy, an average of 18 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Heparin, Low-Molecular-Weight', 'compliance', 'drug safety', 'self-administration', 'ambulatory Care', 'Pharmaceutical Services'], 'conditions': ['Thromboembolism']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Mengiardi S, Tsakiris DA, Molnar V, et al. Impact of Pharmaceutical Care on Self-Administration of Outpatient Low-Molecular-Weight Heparin Therapy. Pharmacology & Pharmacy 5: 372-385, 2014'}]}, 'descriptionModule': {'briefSummary': 'There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment.\n\nHypothesis:\n\nIntensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.', 'detailedDescription': 'Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients.\n\nData collection:\n\n* telephone interviews with structured questionnaires at the beginning and at the end of the therapy\n* monitored self-injection in the study center or at patient\'s home (direct observation technique \\[DOT\\])\n* compliance measurement: answers from patient interviews, comparing number of used syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes\n* recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder and Hand" questionnaire (DASH questionnaire)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment.\n* self-application of the LMWH\n* german / english speaking\n\n -\\> clinical setting:\n* Dalteparin\n\n -\\> daily life setting:\n* all LMWH (ready-to-use syringes)\n* control group: self-application or application by another person (family member, medical person, etc.)\n\nExclusion Criteria:\n\n\\- patient's home far away from study center"}, 'identificationModule': {'nctId': 'NCT00794560', 'briefTitle': 'Self-management of Low Molecular Weight Heparin Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care', 'orgStudyIdInfo': {'id': 'NRA 630 00 23'}, 'secondaryIdInfos': [{'id': 'EKBB 95/07', 'type': 'OTHER', 'domain': 'ethics committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'clinical setting: intervention', 'description': "Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.\n\nIntervention: patient education", 'interventionNames': ['Behavioral: patient education']}, {'type': 'NO_INTERVENTION', 'label': 'clinical setting: standard care', 'description': 'Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)'}, {'type': 'EXPERIMENTAL', 'label': 'daily life setting: intervention', 'description': 'Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.\n\nIntervention: patient education', 'interventionNames': ['Behavioral: patient education']}, {'type': 'NO_INTERVENTION', 'label': 'daily life setting: standard care', 'description': 'Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)'}], 'interventions': [{'name': 'patient education', 'type': 'BEHAVIORAL', 'description': "Possible, individualized interventions:\n\n* Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material\n* Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)\n* Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom\n* First self-injection under control of a specially trained pharmacist", 'armGroupLabels': ['clinical setting: intervention', 'daily life setting: intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital of Basle, Switzerland', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-4101', 'city': 'Bruderholz', 'country': 'Switzerland', 'facility': 'Kantonsspital Baselland, Switzerland', 'geoPoint': {'lat': 47.5296, 'lon': 7.59902}}], 'overallOfficials': [{'name': 'Kurt E. Hersberger, Prof. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pharmaceutical Care Research Group, University of Basle, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pfizer', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}