Impact of a Nurse for Migraine Management: the IMPACT Project

NCT01804517 | Completed

• 1 other identifier: IMPACT
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Headache disorders are prevalent, disabling, under recognized, under diagnosed and under treated. Migraine has a prevalence of 10% in men and 25% in women in Canada. The treatment of migraine is based on patient education (lifestyle habit modification, trigger avoidance), and pharmacological acute treatment and prophylaxis. A multidisciplinary approach allows a repartition of tasks between different health professionals. In a 2010 meeting, the Canadian Headache Society members supported the concept of Headache Centers, and a headache nurse was judged as an essential component of such centers. Gaul has reviewed the structured multidisciplinary approach that could be used in a headache centre and the existing studies using such structures. Five studies did include a headache nurse. No study did observe the impact of a nurse only. Resources in medical care are limited. One study did use a program of 96 hours, which does not seem realistic on the long-term and for a large pool of patients in a public hospital. Patients are not always able to pay for paramedical help such as physiotherapy and psychotherapy. Even if they do, finding a specialized therapist for chronic headache is difficult. Defining the role of a nurse and demonstrating the impact on patient care is therefore a first step in the concept of a headache center. Possible roles of a headache nurse according to Gaul are patient education, follow-up of the treatment plan, addressing patient queries, and monitoring of patient progress. The headache nurse may also participate in research projects. In a hospital Headache Clinic, the nurse may be involved in intra-venous treatments and blood sampling for research. In summary, evidence to demonstrate the impact of a nurse in a headache clinic is lacking. We propose to study this aspect prospectively. A study with positive findings would encourage health ministers to fund and support headache nurses for headache centers across Canada for headache management. Chronic headache and therefore chronic migraine would be a focus of such centers, since most patients seen in specialized centers are chronic. HYPOTHESIS: The addition of a headache nurse to the headache team will help the CHUM Migraine Clinic to improve treatment outcome, and reduce the burden of headache. This multidisciplinary approach will also allow a higher efficiency of the team.

Conditions

Migraine Without Aura; Migraine With Aura; Chronic Migraine

Keywords

migraine

Outcome Measures

Primary Outcomes (1)

• Hit-6 score change

  HIT-6 score change between inclusion and 8 month.

  Baseline and 8 months

Secondary Outcomes (14)

• Frequency of moderate and severe headache days

  Baseline and 8 months

• Frequency of headache days

  Baseline and 8 months

• Chronic headache status

  Baseline and 1 year

• Medication overuse

  Baseline and 8 months

• Acute medication intake

  Baseline and 8 months

Study Arms (2)

Physician based approach

Patients will be managed as usual at the clinic without the intervention of the nurse.

Physician and nurse

Patients will be managed with the help of the nurse for education and follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed at the migraine clinic at the Notre-Dame Hospital in Montreal

You may qualify if:

• Age 18 or more
• Diagnosis of migraine, chronic or episodic, at the first visit. We expect the majority of patients to suffer form frequent or chronic migraine.
• Consent to participate in the CHUM Migraine Clinic IMPACT project.
• For future post-hoc analysis, groups will be stratified according to baseline headache frequency (all severity included), assessed retrospectively at the first visit:
• \<6 headache days per month,
• to 14 headache days per month
• or more headache days per month

You may not qualify if:

• Patients whom first headache diagnosis is not migraine (for example post-traumatic headache, cluster headache, trigeminal neuralgia, facial pain).
• Women with ongoing or planned pregnancy.
• Patient with an active psychiatric condition (needing hospitalisation or psychosis).
• Patient with mental retardation impairing assessment or follow-up.
• Patient with an active medical condition which may lead to frequent hospitalisations (eg active cancer, organ graft, hemodialysis etc). This will be determined and detailed by the evaluating physician.
• Active drug addiction or alcoholism.
• Active follow-up at a pain clinic.
• Patient speaking a language other than french and incapable to communicate in a reliable way.

Sponsors & Collaborators

• Notre-Dame Hospital, Montreal, Quebec, Canada: lead
• Allergan: collaborator

Study Sites (1)

Hôpital Notre-Dame

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Migraine without Aura; Migraine with Aura; Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Elizabeth Leroux, M.D.

  FRCPC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D. Neurologist, FRCPC

Study Record Dates

• First Submitted: February 23, 2013
• First Posted: March 5, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

CA (1)