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临床试验/NCT06200480
NCT06200480终止不适用

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

Norwegian University of Science and Technology1 个研究点 分布在 1 个国家目标入组 147 人开始时间: 2023年4月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
147
试验地点
1
主要终点
Compliance

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Telephone by nurse (Other)

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

结局指标

主要结局

Compliance

时间窗: 2 months

number of participants who have carried out the prescribed preventive treatment, as in minimum duration of two months after the initial visit

次要结局

  • Responders(3 months)
  • Number of days to at least a 30% reduction(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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