Leiden Improvement of MIgraine Therapy in general practice

ISRCTN	ISRCTN72421511
DOI	https://doi.org/10.1186/ISRCTN72421511
Protocol serial number	N/A
Sponsor	Leiden University Medical Center (LUMC) (The Netherlands)
Funders	Stichting Nuts Ohra (The Netherlands), Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr J W Blom
Scientific

Leiden University Medical Center (LUMC)
Department of Public Health and Primary Care
Postzone V-0-P
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 8406
Email	J.W.Blom@lumc.nl

Primary study design	Interventional
Study design	Randomised, controlled, parallel group, multicentre trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	LIMIT-study
Study objectives	The aim of the study is to optimise therapy of migraine patients, according to the Dutch General Practitioner (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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Migraine
Intervention	Intervention: Proactive stepped approach based on the Dutch GP Guideline: Step one: a letter to invite patients for consultation. Step two: 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.
Intervention type	Other
Primary outcome measure(s)	Headache Impact Test (HIT-6) score at baseline and after three, six, nine and 12 months.
Key secondary outcome measure(s)	1. The health-related quality of life (self reported EuroQoL [EQ-5D] questionnaire and visual analogue scale) 2. Migraine characteristics 3. Medication use 4. Social effects of migraine including absence at work Measured at baseline and after three, six, nine and 12 months.
Completion date	01/03/2010

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	600
Key inclusion criteria	Patients in general practice using more than or equal to 24 Defined Daily Doses (DDD) triptans (or more than or equal to six DDDs in the last three months), enlisted in 60 general practices, that are part of LEON (Leiden Eerstelijns OnderzoeksNetwerk), managed by the department of Public Health and Primary Care.
Key exclusion criteria	1. Younger than 18 years 2. Cognitive impairment 3. Psychiatric illness 4. Terminal illness 5. Non-Dutch speaking
Date of first enrolment	01/03/2007
Date of final enrolment	01/03/2010

Leiden University Medical Center (LUMC)

Leiden
2300 RC
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	06/03/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes