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Leiden Improvement of MIgraine Therapy in general practice.


- candidate number2367
- NTR NumberNTR840
- ISRCTNISRCTN72421511
- Date ISRCTN created22-jan-2007
- date ISRCTN requested12-jan-2007
- Date Registered NTR13-dec-2006
- Secondary IDsN/A 
- Public TitleLeiden Improvement of MIgraine Therapy in general practice.
- Scientific TitleTriptan overuse in migraine in primary care, a proactive approach.
- ACRONYMLIMIT-study
- hypothesisThe aim of the study is to optimize therapy of migraine patients, according to the Dutch GP Guideline for headache and consequently reduce the use of triptans. The project will explore the costs and effects of a proactive approach of patients with triptan use by GPs.
- Healt Condition(s) or Problem(s) studiedMigraine
- Inclusion criteriaPatients in general practice using 24 DDD triptans (or 6 DDDs in the last 3 months), enlisted in 60 general practices, that are part of LEON (the Leiden Eerstelijns Onderzoeksnetwerk, managed by the department of Public Health and Primary Care).
- Exclusion criteria1. Younger than 18 years; 2. Cognitive impairment; 3. Psychiatric illness; 4. Terminal illness; 5. Non-Dutch speaking.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate1-mrt-2010
- Target number of participants600
- InterventionsProactive stepped approach based on the Dutch GP Guideline versus usual care. Step 1: a letter to invite patients for consultation. Step 2: a visit to the GP, who can give information about headache and therapy, reduce/stop the triptans, prescribe prophylactic therapy or reconsider the diagnosis of migraine. Control group: care as usual.
- Primary outcomeHIT-6 (Headache Impact Test)-score at baseline and after 3, 6, 9 and 12 months.
- Secondary outcome1. The health-related quality of life (self reported EQ-5D and visual analogue scale); 2. Migraine characteristics; 3. Medication use; 4. Social effects of migraine including absence at work. Measured at baseline and after 3, 6, 9 and 12 months.
- Timepoints
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.W. Blom
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.J.J. Assendelft
- Sponsor/Initiator Leiden University Medical Center (LUMC), Department of Public Health and Primary Care
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Stichting Nuts Ohra
- PublicationsN/A
- Brief summaryWe aim to study the costs and effects of a pro-active approach of migraine patients by the General Practitioner. The design is a pragmatic cluster randomised controlled trial with the general practice as the unit of randomisation. Patients using >=24 DDD's triptans are selected from the EMD and invited by mail to consult their GP. Diagnosis and treatment plan of migraine will be evaluated and discussed. Patients will be offered prophylactic treatment according to the Dutch Guidelines (NHG-standaard). The control group will receive usual care. The primary outcome is the score on the HIT-6 questionnaire.
- Main changes (audit trail)
- RECORD13-dec-2006 - 16-mei-2007


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