Medicine Abuse Headache

Migraine Clinical Trial

— CAM-ET  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170793
• Other study ID #: CHUBX 2009/16
• Status: Completed
• Phase: N/A
• First received: July 26, 2010
• Last updated: December 26, 2012
• Start date: August 2010
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Migraine

Intervention

Behavioral:
• educative telephone coaching (ETC)
a 30 to 45 minutes phone call, by appointment, by the nurse

Locations

Country	Name	City	State
France	Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Fondation Apicil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.		within 6 months	No
Secondary	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	No
Secondary	To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)		within 6 months	No
Secondary	To evaluate the patient's satisfaction toward ETC		within 6 months	No
Secondary	To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC		within 6 months	No
Secondary	To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.		within 6 months	No