Medicine Abuse Headache - Full Text View

Sponsor:	University Hospital, Bordeaux
Collaborator:	foundation APICIL
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT01170793

Purpose

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

Condition	Intervention
Migraine	Behavioral: educative telephone coaching (ETC)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Medication Overuse Headaches: the Impact of Educative Telephone Coaching Administered by Nurses Prior to the Medical Appointment in a Tertiary Consultation Center: a Comparative Randomized Trial

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine

U.S. FDA Resources

Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:

To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data) [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
To evaluate the patient's satisfaction toward ETC [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC [ Time Frame: within 6 months ] [ Designated as safety issue: No ]
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment. [ Time Frame: within 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	68
Study Start Date:	August 2010
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: 2 no educative telephone coaching (ETC)
Experimental: 1 with educative telephone coaching (ETC)	Behavioral: educative telephone coaching (ETC) a 30 to 45 minutes phone call, by appointment, by the nurse

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170793

Contacts

Contact: Virginie Dousset, MD	33 (0) 56-79-87-11	virginie.dousset@chu-bordeaux.fr
Contact: Elodie GALLIAUD, MD	33 (0) 56-79-87-11	elodie.galliaud@chu-bordeaux.fr

Locations

France
Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard	Recruiting
Bordeaux, France, 33076
Contact: Virginie Dousset, MD 05-56-79-87-11
Contact: Maria Merched maria.merched@chu-bordeaux.fr
Principal Investigator: Virginie Dousset, MD
Sub-Investigator: Elodie Gaillaud, MD

Sponsors and Collaborators

University Hospital, Bordeaux

foundation APICIL

Investigators

Study Chair:	Geneviève Chene, MD PhD	University Hospital, Bordeaux
Principal Investigator:	Virginie Dousset, MD	UH Bordeaux

More Information

No publications provided

Responsible Party:	Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT01170793 History of Changes
Other Study ID Numbers:	CHUBX 2009/16
Study First Received:	July 26, 2010
Last Updated:	March 3, 2011
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

education, quality of life

Additional relevant MeSH terms:

Headache
Migraine Disorders
Pain
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases

ClinicalTrials.gov processed this record on February 09, 2012