Completed

IMPACTImpact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+5

+ Central Nervous System Diseases

+ Nervous System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: February 2013
See protocol details

Summary

Principal SponsorNotre-Dame Hospital, Montreal, Quebec, Canada
Last updated: December 8, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

STUDY DESIGN: The goal of this study is to compare two treatment approaches for migraineurs. The first approach will be based on the physician only and is limited to fixed appointments (control group). The second approach will be based on a team involving a headache nurse (active group) who will participate in patient education and follow-up. The goal is to improve patient outcome but also physician productivity. First 100 patients (control group, phase 1): patients with episodic and chronic migraine will be screened, sign consent and be enrolled. They will be seen by the physician only, without the nurse's support. This situation will reproduce the actual conditions at the clinic. During this phase, the nurse will be involved in the follow-up of known patients (who will not be included in the protocol) and data collection. She will develop her headache management abilities and help the physicians to develop some educational tools for patients. Following 100 patients (active group, phase 2) : patients with episodic and chronic migraine will be screened and enroled. They will be seen by the physician and nurse team, with a treatment plan tailored to specific needs including regular scheduled visits, follow-up of chronification factors and educational sessions. Phone call follow-ups will be planned. Patients will have an easier and quicker contact with the team in an emergency situation.

Principal SponsorNotre-Dame Hospital, Montreal, Quebec, Canada
Last updated: December 8, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache DisordersHeadache Disorders, PrimaryMigraine DisordersMigraine with AuraMigraine without Aura

Criteria

INCLUSION CRITERIA: 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, 6 to 14 headache days per month 15 or more headache days per month EXCLUSION CRITERIA: 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Hôpital Notre-Dame

Montreal, CanadaOpen Hôpital Notre-Dame in Google Maps
CompletedOne Study Center