Migraine Without AuraIMPACTNCT01804517
Impact of a Nurse for Migraine Management: the IMPACT Project
An observational study of Migraine Without Aura and Migraine With Aura, run by Notre-Dame Hospital, Montreal, Quebec, Canada at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2013to Nov 2015
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed at the migraine clinic at the Notre-Dame Hospital in Montreal
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- Keywords
- migraine
- Medical subject headings
- Migraine without Aura, Migraine with Aura, Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hit-6 score change
HIT-6 score change between inclusion and 8 month.
Measured: Baseline and 8 months
Secondary outcomes (14)
Frequency of moderate and severe headache days
Variation in the frequency of moderate or severe headache days per month between the first, fourth and eighth month after inclusion.
Measured: Baseline and 8 months
Frequency of headache days
Change in the frequency of headache days, all severity included, between the first month and the seventh and eight months following inclusion.
Measured: Baseline and 8 months
Chronic headache status
Percent of patients who were chronic (more than 3 months with >15 headache days per month, retrospective) at entry and were episodic at one year (according to calendars).
Measured: Baseline and 1 year
Medication overuse
Percent of patients with medication overuse at entry and were not overusing anymore at 8 months.
Measured: Baseline and 8 months
Acute medication intake
Change in the number of days per month with acute medication use between the first month after inclusion and the seventh and eight months following inclusion.
Measured: Baseline and 8 months
Efficacy of acute treatment
Percent of patients who succeeded in finding a successful and properly used acute treatment at month eight, according to four criteria: efficacy, reliability, absence of recurrence, absence of significant side effects.
Measured: at 8 months
Response rate to prophylactics
Percent of patients who did complete a successful (>50% response and no significant side-effects) preventive treatment trial at month eight after inclusion.
Measured: at 8 months
Short Form 12 score
Change in SF-12 scores between inclusion and third visit. SF-12 is a quality of life questionnaire.
Measured: Baseline and 8 months
Visits to the emergency department
Number of headache-related emergency department visits per patient during the year following their inclusion.
Measured: over 1 year
Severe adverse effects from treatments
Percent of patients with a severe adverse effect from a treatment (necessitating hospitalization, emergency visit or specific treatment).
Measured: over 1 year
Phone calls returned
Number of phone calls returned per month
Measured: per 1 month
Patient satisfaction
Satisfaction of patients, evaluated by a customized questionnaire.
Measured: at 8 months
Phone call return delay
Mean delay for returning the call (number of week days between the date of the call and the date of the return).
Measured: for each phone call, mean
Global improvement
Evaluation of physician of the global improvement of the patient.
Measured: at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Notre-Dame Hospital, Montreal, Quebec, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Principal investigator, Elizabeth Leroux, Notre-Dame Hospital, Montreal, Quebec, Canada
- Investigators
- Elizabeth Leroux, M.D., Principal investigator, FRCPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01804517
- Sponsor's protocol ID
- IMPACT
- Acronym
- IMPACT
- Status last verified
- Dec 2016
- First submitted
- 23 Feb 2013
- Last updated
- 8 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Nursing Intervention on the Clinical Evolution of Patients at a University Migraine Clinic
- ClinicalTrials.gov ID
- NCT01804517
- Acronym / sponsor ID
- IMPACT / IMPACT
- Conditions
- Migraine Without Aura, Migraine With Aura, Chronic Migraine
- Keywords
- migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Notre-Dame Hospital, Montreal, Quebec, CanadaUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Feb 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 5 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed at the migraine clinic at the Notre-Dame Hospital in Montreal
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hit-6 score change
Time frame: Baseline and 8 months
HIT-6 score change between inclusion and 8 month.
14 secondary outcomes
Frequency of moderate and severe headache days
Time frame: Baseline and 8 months
Frequency of headache days
Time frame: Baseline and 8 months
Chronic headache status
Time frame: Baseline and 1 year
Medication overuse
Time frame: Baseline and 8 months
Acute medication intake
Time frame: Baseline and 8 months
Efficacy of acute treatment
Time frame: at 8 months
Response rate to prophylactics
Time frame: at 8 months
Short Form 12 score
Time frame: Baseline and 8 months
Visits to the emergency department
Time frame: over 1 year
Severe adverse effects from treatments
Time frame: over 1 year
Phone calls returned
Time frame: per 1 month
Patient satisfaction
Time frame: at 8 months
Phone call return delay
Time frame: for each phone call, mean
Global improvement
Time frame: at 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Leroux, M.D. principal investigator
FRCPC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Without Aura and Migraine With Aura, run by Notre-Dame Hospital, Montreal, Quebec, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hit-6 score change (time frame: Baseline and 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.