Condition category
Nervous System Diseases
Date applied
22/01/2007
Date assigned
22/01/2007
Last edited
10/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lumc.nl/english/start_english.html

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)

Netherlands Organisation for Health Research and Development

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22231680

Publication citations

  1. 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.

Additional files

Editorial Notes