Contact information
Type
Scientific
Primary contact
Dr J W Blom
ORCID ID
Contact details
Leiden University Medical Center (LUMC)
Department of Public Health and Primary Care
Postzone V-0-P
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 8406
J.W.Blom@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
LIMIT-study
Study hypothesis
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
Not provided at time of registration
Study design
Randomised, controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Headache Impact Test (HIT-6) score at baseline and after three, six, nine and 12 months.
Secondary outcome measures
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.
Overall trial start date
01/03/2007
Overall trial end date
01/03/2010
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
600
Participant exclusion criteria
1. Younger than 18 years
2. Cognitive impairment
3. Psychiatric illness
4. Terminal illness
5. Non-Dutch speaking
Recruitment start date
01/03/2007
Recruitment end date
01/03/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (LUMC) (The Netherlands)
Sponsor details
Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Stichting Nuts Ohra (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22231680
Publication citations
-
Results
Smelt AF, Blom JW, Dekker F, van den Akker ME, Knuistingh Neven A, Zitman FG, Ferrari MD, Assendelft P, A proactive approach to migraine in primary care: a pragmatic randomized controlled trial., CMAJ, 2012, 184, 4, E224-31, doi: 10.1503/cmaj.110908.