Medicine Abuse Headache

Not Applicable

Completed

• Conditions: Migraine
• Interventions: Behavioral: educative telephone coaching (ETC)

• Registration Number: NCT01170793
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-07-26
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Study Start: 2010-08
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-26
• Last Update Posted: 2012-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	educative telephone coaching (ETC)	with educative telephone coaching (ETC)

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.	within 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake.	within 6 months
To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)	within 6 months
To evaluate the patient's satisfaction toward ETC	within 6 months
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC	within 6 months
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.	within 6 months

Trial Locations

Locations (1)

Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard; 🇫🇷 Bordeaux, France