Nurse follow-up for headache patients starting preventive treatment
Nurse Intervention Trial: The Evaluation of Usefulness of a Headache Nurse
NA · Norwegian University of Science and Technology · NCT06200480
This study is testing if follow-up care from a headache nurse over the phone helps people starting preventive treatment for headaches feel more satisfied and stick to their medication better than regular follow-up with their doctor.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Norwegian University of Science and Technology (other) |
| Locations | 1 site (Trondheim) |
| Trial ID | NCT06200480 on ClinicalTrials.gov |
What this trial studies
This randomized open-label prospective study focuses on patients with various types of headaches who are beginning preventive treatment. It compares the effectiveness and patient satisfaction of follow-up care provided by a headache nurse through telephone consultations versus standard follow-up initiated by the patient's general practitioner. Eligible patients will have undergone a neurological consultation and will be prescribed preventive medication, after which they will be randomized into one of the two follow-up groups. The study aims to clarify whether nurse-led follow-up improves compliance and overall satisfaction.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with chronic tension-type headache, migraine, cluster headache, or hemicrania continua who require preventive medication.
Not a fit: Patients with uncertain headache diagnoses or those needing further investigation or treatment for other comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient satisfaction and treatment compliance for individuals suffering from chronic headaches.
How similar studies have performed: Other studies have shown positive outcomes with nurse-led follow-up interventions in chronic headache management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Trondheim
- St. Olavs Hospital HF — Trondheim, Norway (RECRUITING)
Study contacts
- Study coordinator: Knut Hagen
- Email: knut.hagen@stolav.no
- Phone: 95401579
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Migraine, Chronic Tension-Type Headache, Cluster Headache, Hemicrania Continua