Nurse Intervention Trial

Migraine Clinical Trial

Official title:

Nurse Intervention Trial: The Evaluation of Usefulness of a Headache Nurse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06200480
• Other study ID #: 2023-554940
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: Norwegian University of Science and Technology
• Contact: Knut Hagen
• Phone: 95401579
• Email: knut.hagen[@]stolav.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized open-label prospective study focus on headache patients initiating preventive treatment, where the treating physician identifies a need for follow-up visits in specialized healthcare. The study will clarify whether the implementation (compliance) and overall satisfaction of the patient are better with follow-up by a headache nurse compared to standard follow-up. Patients with signed written consent will be randomised to either group a: Telephone calls from nurse after two and 6 week or B. Patient-initiated follow-up by their general practitioner.

Description:

Potential patients suitable for this study must have undergone a regular consultation with a neurologist before. This consultation includes neurological and somatic examinations, diagnosis of the type of headache based on medical history, review of a completed headache diary, and any additional conducted examinations. The consultation will also involve an assessment of the possible initiation of preventive treatment. A selection of these patients will be prescribed electronic prescriptions for at least one previously untried type of preventive medication. During the consultation, patients will receive oral and written information about the dosage and expected possible side effects of the preventive medication. Those eligible for beta-blocker initiation will undergo an electrocardiogram (EKG) after the consultation. After completing the consultation, eligible patients will receive written and oral information about the study. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• One of the following headache diagnoses based on the International Classification of Headache Disorders, third edition (ICDH3): G44.2 Chronic tension-type headache and/or G43 Episodic and chronic migraine, G44.0 Episodic and chronic cluster headache, G44.8 Hemicrania Continua
• Indication for preventive medication where there is at least one alternative with the need for follow-up assessment of effectiveness.

Exclusion Criteria:

• Uncertain headache diagnosis.
• 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

Related Conditions & MeSH terms

• Chronic Tension-Type Headache
• Cluster Headache
• Headache
• Hemicrania Continua
• Migraine
• Tension-Type Headache

Intervention

Other:
• Telephone by nurse
Patient-initiated follow-up at week 2 and 6

Locations

Country	Name	City	State
Norway	St. Olavs Hospital HF	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Haukeland University Hospital, Oslo University Hospital, St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	number of participants who have carried out the prescribed preventive treatment, as in minimum duration of two months after the initial visit	2 months
Secondary	Number of days to at least a 30% reduction	Number of days from inclusion to at least a 30% reduction erate to severe headache compared to in the frequency in the last month before the initial consultation	3 months
Secondary	Responders	Numbers of responders defined as> 50% decrease in headache days compared to in the frequency in the last month before the initial consultation	3 months

External Links

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