Leiden Improvement of MIgraine Therapy in general practice
| ISRCTN | ISRCTN72421511 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72421511 |
| Secondary identifying numbers | N/A |
- Submission date
- 22/01/2007
- Registration date
- 22/01/2007
- Last edited
- 10/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr J W Blom
Scientific
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 |
|---|---|
| J.W.Blom@lumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2007 |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Research organisation
Stichting Nuts Ohra (The Netherlands)
No information available
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/03/2012 | Yes | No |
