Nurse Intervention Trial

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

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.

Study Overview

• Status: Recruiting
• Conditions: Migraine; Cluster Headache; Chronic Tension-Type Headache; Hemicrania Continua
• Intervention / Treatment: Other: Telephone by nurse

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.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Knut Hagen; Phone Number: 95401579; Email: knut.hagen@stolav.no
• Study Contact Backup: Name: Erling Tronvik; Phone Number: 40008646; Email: erling.tronvik@ntnu.no

Study Locations

• Norway
  • Trondheim, Norway, 7489
    • Recruiting
    • St. Olavs Hospital HF
    • Contact: Knut Hagen, MD, PhD; Phone Number: 95401579; Email: knut.hagen@stolav.no
    • Contact: Erling Tronvik, MD, PhD; Phone Number: 40008646; Email: erling.tronvik@ntnu.no
    • Principal Investigator: Knut Hagen, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Telephone by nurse; Patient-initiated follow-up at week 2 and 6
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Oslo University Hospital; Haukeland University Hospital; St. Olavs Hospital
• Investigators: Study Chair: Geir Braathen, St. Olavs Hospital, Trondheim, Norway

Publications and helpful links

Helpful Links

• Information by request

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 11, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Trigeminal Autonomic Cephalalgias; Headache; Tension-Type Headache; Cluster Headache
• Other Study ID Numbers: 2023-554940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication by home page of NorHead
• IPD Sharing Time Frame: In the near future
• IPD Sharing Access Criteria: https://www.ntnu.no/norhead/om
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Study Data/Documents

1. Study Protocol
   Information identifier: NorHead
   Information comments: English Study protocol available by request to the Norwegian Centre of Headache Research (NorHead)
2. Statistical Analysis Plan
   Information identifier: NorHead
   Information comments: English SAP available by request to the the Norwegian Centre of Headache Research (NorHead)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No