Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT01078012
Status:
COMPLETED
Last Update Posted:
2015-12-30
First Post:
2010-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Short Intervention for Medication Overuse Headache (MOH) - Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051271', 'term': 'Headache Disorders, Secondary'}], 'ancestors': [{'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-29', 'studyFirstSubmitDate': '2010-03-01', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2015-12-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative comments of participants on acceptability and utility', 'timeFrame': '2 months'}], 'secondaryOutcomes': [{'measure': 'Qualitative comments of participants on acceptability and utility.', 'timeFrame': '2 months'}, {'measure': 'Number of medication days per month', 'timeFrame': '2 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Medication Overuse Headache']}, 'referencesModule': {'references': [{'pmid': '24646429', 'type': 'DERIVED', 'citation': 'Kristoffersen ES, Straand J, Russell MB, Lundqvist C. Feasibility of a brief intervention for medication-overuse headache in primary care--a pilot study. BMC Res Notes. 2014 Mar 20;7:165. doi: 10.1186/1756-0500-7-165.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is together with the BIMOH (NCT01314768) RCT study to evaluate whether training of GPs in the detection and treatment of medication overuse headache leads to improved care for these patients as compared to "business as usual".', 'detailedDescription': 'The present pilot study focuses on testing the logistics and the methodology of short intervention on a pilot group of GPs and their patients.\n\nDue to low recruitment and the pilot study focus on logistics and methodology, the study was changed to not include a control (business as usual) arm. The outcomes were evaluated as "before - after" data and qualitative comments on acceptability and utility of the method. Primary outcomes were changed to be the acceptability and utility (previously listed as secondary outcomes) while secondary outcomes were headache days and medication days (previously listed as primary).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with medication overuse headache\n\nExclusion Criteria:\n\n* Other complicating pain condition'}, 'identificationModule': {'nctId': 'NCT01078012', 'acronym': 'SIMOHpilot', 'briefTitle': 'Short Intervention for Medication Overuse Headache (MOH) - Pilot', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Pilot Study of Short Intervention for Medication Overuse Headache in General Practice', 'orgStudyIdInfo': {'id': 'SIMOH pilot'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Trained counselling', 'description': 'Comparison of outcomes before intervention vs. 2 months after', 'interventionNames': ['Behavioral: Trained counselling']}], 'interventions': [{'name': 'Trained counselling', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Trained counselling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0318', 'city': 'Oslo', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Department of General Practice and Community Medicine', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Department of General Practice and Community Medicine, Oslo', 'class': 'UNKNOWN'}, {'name': 'Head and Neck Research Group, Lørenskog', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christofer Lundqvist', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}