No registrations found.
ID
Source
Brief title
Health condition
migraine
Sponsors and support
Stichting Nuts Ohra
Intervention
Outcome measures
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.
Background 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.
Study objective
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.
Intervention
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.
Postzone V-0-P,
P.O. Box 9600
J.W. Blom
Leiden 2300 RC
The Netherlands
+31 (0)71 5268406
J.W.Blom@lumc.nl
Postzone V-0-P,
P.O. Box 9600
J.W. Blom
Leiden 2300 RC
The Netherlands
+31 (0)71 5268406
J.W.Blom@lumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL827 |
| NTR-old | NTR840 |
| Other | : N/A |
| ISRCTN | ISRCTN72421511 |