Clinical trial NCT06200480: Nurse Intervention Trial
Official title: Nurse Intervention Trial: The Evaluation of Usefulness of a Headache Nurse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Chronic Tension-Type Headache
Cluster Headache
Hemicrania Continua
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Oslo University Hospital
name: St. Olavs Hospital
First posted: 2024-01-11
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open-label randomized prospetive study
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compliance
timeFrame: 2 months
Secondary outcomes:
measure: Number of days to at least a 30% reduction
timeFrame: 3 months
measure: Responders
timeFrame: 3 months
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF
Study officials:
affiliation: St. Olavs Hospital, Trondheim, Norway
name: Geir Braathen
role: STUDY_CHAIR
References: