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Medicine Abuse Headache

NCT ID: NCT01170793

Last Updated: 2012-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-06-30

Brief Summary

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In patients with MOH, we will evaluate the impact of educative telephone coaching on the number of days with headache over the month preceding the appointment. The educative coaching will be administered by a nurse, during a single phone call and prior to the medical visit

Detailed Description

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In tertiary centers, it is not unusual for patients to wait for 6 months for a medical appointment. This clinical trial is monocentric, open, randomised. In the first arm, the patients will receive educative telephone coaching at Month 2 by the nurses, over the phone. In the second arm, the patients will not receive any educative telephone coaching before the appointment with the neurologist.

All patients will complete "Quality of life" questionnaires at Month 1 and Months 6, complete a migraine agenda during the length of the study and have a medical appointment around Month 6.

The primary outcome will be the efficacy of such educative telephone coaching, administered before the medical appointment in the Chronic Pain Center, in Bordeaux. It will be measured by the number of days with headache over the month preceding the appointment.

Conditions

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Migraine

Keywords

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education, quality of life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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2

no educative telephone coaching (ETC)

Group Type NO_INTERVENTION

No interventions assigned to this group

1

with educative telephone coaching (ETC)

Group Type EXPERIMENTAL

educative telephone coaching (ETC)

Intervention Type BEHAVIORAL

a 30 to 45 minutes phone call, by appointment, by the nurse

Interventions

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educative telephone coaching (ETC)

a 30 to 45 minutes phone call, by appointment, by the nurse

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adults, male or female, \> 18 years old
* Patients with a presumptive medication overuse headache diagnostic (\>15 days/month with migraines, \> 10 days/month intake of crisis treatment)
* Persons calling the Chronic Pain Center in Bordeaux and asking for a medical appointment
* Informed and written consent, dated and signed by the patient and the investigator prior to any study related procedure

Exclusion Criteria

* Patients with a differential diagnostic (other primitive headaches and secondary headaches)
* Persons non affiliated to a social security system
* Persons who refuse to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Apicil

OTHER

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Geneviève Chene, MD PhD

Role: STUDY_CHAIR

University Hospital, Bordeaux

Virginie Dousset, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2009/16

Identifier Type: -

Identifier Source: org_study_id