Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2026-02-28 @ 9:25 PM
Study NCT ID:
NCT02768233
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2019-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-02', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-09', 'lastUpdatePostDateStruct': {'date': '2023-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache frequency measured by self-reported headache diary on number of days with headache previous month', 'timeFrame': 'baseline-36 weeks follow-up'}], 'secondaryOutcomes': [{'measure': 'NEO-FFI-3 personality test', 'timeFrame': 'Baseline', 'description': 'self reported. 63 items. Each item scores using a 5 point Likert scale ranging from 1 (strongly disagree) to 5 (strongly agree)'}, {'measure': 'Coping Strategies', 'timeFrame': 'Baseline, Post intervention (16 weeks), Follow-up (36 weeks)', 'description': 'CSQ Questionnaire (Scale ranging from 0 (never) to 6 (always)'}, {'measure': 'Pain Intensity', 'timeFrame': 'Baseline, Post intervention (16 weeks), Follow-up (36 weeks)', 'description': 'VAS (0: No pain, 10: Pain as bad as it can be)'}, {'measure': 'Bothersomeness', 'timeFrame': 'Baseline, Post intervention (16 weeks), Follow-up (36 weeks)', 'description': 'VAS (0: No bothersomeness, 10: Bothersomeness as bad as it can be)'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Baseline, Post intervention (16 weeks), Follow-up (36 weeks)', 'description': 'Questionnarire'}, {'measure': 'Medication intake', 'timeFrame': 'baseline, Post intervention (16 weeks) and Follow-up (36 weeks)', 'description': 'self reported intake (type, name of medication, dosis)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Medication-overuse Headache', 'Educational Programme', 'Personality Profiles'], 'conditions': ['Secondary Headache Disorders', 'Medication-overuse Headache']}, 'referencesModule': {'references': [{'pmid': '31661579', 'type': 'DERIVED', 'citation': 'Mose LS, Pedersen SS, Jensen RH, Gram B. Medication-overuse headache: The effect of a patient educational programme-A randomized controlled trial. Eur J Pain. 2020 Feb;24(2):435-447. doi: 10.1002/ejp.1500. Epub 2019 Nov 21.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the influence of personality profiles in patients with MOH and to evaluate the effect of a custom-made educational programme as an add-on to standard treatment as compared to standard treatment alone in MOH patients using a randomized controlled trial (RCT) design.', 'detailedDescription': 'Worldwide, two percent of the population suffers from medication-overuse headache (MOH), a paradox condition where the headache is caused by overuse of headache medication. Common treatment is withdrawal, but there is no consensus on what constitutes the best treatment.\n\nThe study consists of a RCT with MOH patients randomized to standard treatment versus standard treatment + a 12-week, 6-session educational programme as add-on. The programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups.\n\nPrimary endpoint: Headache frequency measured by self-reported headache diary on number of days with headache pre-vious month. Secondary endpoints: NEO-FFI-3 personality test, coping strategies, pain intensity, bothersomeness, patient satis-faction and reported medication intake.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with medication-overuse headache (MOH) by neurologist (The International Classification of headache Disorders).\n* Completed withdrawal (hospitalized of 8 days or at home).\n* Age 18-65 years\n* Understand and speak Danish\n\nExclusion Criteria:\n\n* Comorbidity (e.g. whiplash, rheumatism which needs analgesic treatment\n* Mental health disorders'}, 'identificationModule': {'nctId': 'NCT02768233', 'briefTitle': 'Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Esbjerg Hospital - University Hospital of Southern Denmark'}, 'officialTitle': 'Medication-overuse Headache: The Effect of a Patient Educational Programme as an add-on to Standard Treatment', 'orgStudyIdInfo': {'id': 'S-20140114'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Educational programme', 'description': 'Group 1: Educational programme + standard treatment', 'interventionNames': ['Behavioral: Educational programme']}, {'type': 'NO_INTERVENTION', 'label': 'Standard treatment', 'description': 'Standard treatment'}], 'interventions': [{'name': 'Educational programme', 'type': 'BEHAVIORAL', 'description': 'The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.', 'armGroupLabels': ['Educational programme']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Louise S. Mose, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital of South West Jutland, Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esbjerg Hospital - University Hospital of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Louise Schlosser Mose', 'investigatorAffiliation': 'Esbjerg Hospital - University Hospital of Southern Denmark'}}}}