| - candidate number | 2367 |
| - NTR Number | NTR840 |
| - ISRCTN | ISRCTN72421511 |
| - Date ISRCTN created | 22-jan-2007 |
| - date ISRCTN requested | 12-jan-2007 |
| - Date Registered NTR | 13-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Leiden Improvement of MIgraine Therapy in general practice. |
| - Scientific Title | Triptan overuse in migraine in primary care, a proactive approach. |
| - ACRONYM | LIMIT-study |
| - hypothesis | The 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) studied | Migraine |
| - Inclusion criteria | Patients in general practice using ¡Ý24 DDD triptans (or ¡Ý6 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 criteria | 1. Younger than 18 years; 2. Cognitive impairment; 3. Psychiatric illness; 4. Terminal illness; 5. Non-Dutch speaking. |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-mrt-2010 |
| - Target number of participants | 600 |
| - Interventions | Proactive 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 outcome | HIT-6 (Headache Impact Test)-score at baseline and after 3, 6, 9 and 12 months. |
| - Secondary outcome | 1. 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 site | N/A |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. J.W. Blom |
| - CONTACT for SCIENTIFIC QUERIES | Prof. 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 |
| - Publications | N/A |
| - Brief summary | We 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) | |
| - RECORD | 13-dec-2006 - 16-mei-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl