Nurse Intervention Trial

NCT06200480 | Terminated

• 1 other identifier: 2023-554940
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of days to at least a 30% reduction

  3 months

• Responders

  3 months

Study Arms (2)

Telephone by nurse

ACTIVE COMPARATOR

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.

Other: Telephone by nurse

Patient-initiated follow-up

NO INTERVENTION

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

Interventions

Telephone by nurse OTHER

Patient-initiated follow-up at week 2 and 6

Telephone by nurse

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• Haukeland University Hospital: collaborator
• Oslo University Hospital: collaborator
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs Hospital HF

Trondheim, 7489, Norway

Location

Related Links

• Information by request

MeSH Terms

Conditions

Migraine Disorders; Cluster Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trigeminal Autonomic Cephalalgias

Study Officials

• Geir Braathen

  St. Olavs Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label randomized prospetive study

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 11, 2024
• Study Start: April 21, 2023
• Primary Completion: January 21, 2026
• Study Completion: January 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: In the near future
• Access Criteria: https://www.ntnu.no/norhead/om

Locations

NO (1)