Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2023-04-21
2027-12-31
Brief Summary
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Detailed Description
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Those who provide consent to participate will, during subsequent registration with the secretaries at the neurological outpatient clinic immediately after the consultation, be randomized to one of two follow-up options (A or B) for further monitoring in the coming months until the scheduled follow-up, set at approximately 3 months, or later if there is a shortage of available appointments.
Group A will be followed up by a headache nurse through telephone consultations on at least two occasions shortly after the initiation of preventive medicine. Participants in this group will be invited to a planned final follow-up appointment after approximately 3 months with a neurologist.
Group B will have patient-managed follow-up with a planned final follow-up appointment after approximately 3 months. Participants will pick up the prescribed medication and contact their general practitioner or the neurological outpatient clinic by a study-specific email if they need advice from a neurologist.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telephone by nurse
The headache patients will be contacted by nurse by phone after approximately 2 week and 6 week after start of preventive medical treatment. The patient will have a follow-up visit by neurologist after 3 months.
Telephone by nurse
Patient-initiated follow-up at week 2 and 6
Patient-initiated follow-up
The headache patient contact their general practitioner (GP) and/or the neurologist by a study-specific email if they have questions regarding the preventive medical treatment
No interventions assigned to this group
Interventions
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Telephone by nurse
Patient-initiated follow-up at week 2 and 6
Eligibility Criteria
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Inclusion Criteria
* Indication for preventive medication where there is at least one alternative with the need for follow-up assessment of effectiveness.
Exclusion Criteria
* Need further investigation after the initial consultation.
* Lack of understanding of information provided in Norwegian, both verbally and in writing.
* Inability to keep a digital headache diary.
* Need treatment of other comorbid conditions requiring follow-up in specialized healthcare.
* Treatment with Onabotulinumtoxin A or Calcitonin-gene-related Peptide (CGRP) inhibitors given with three months intervals
18 Years
90 Years
ALL
No
Sponsors
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Haukeland University Hospital
OTHER
Oslo University Hospital
OTHER
St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Geir Braathen
Role: STUDY_CHAIR
St. Olavs Hospital, Trondheim, Norway
Locations
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St. Olavs Hospital HF
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Study Documents
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Document Type: Study Protocol
English Study protocol available by request to the Norwegian Centre of Headache Research (NorHead)
View DocumentDocument Type: Statistical Analysis Plan
English SAP available by request to the the Norwegian Centre of Headache Research (NorHead)
View DocumentRelated Links
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Information by request
Other Identifiers
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2023-554940
Identifier Type: -
Identifier Source: org_study_id
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