Clinical trial NCT01170793: Medicine Abuse Headache
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Keywords: education, quality of life
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
First posted: 2010-07-27
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.
timeFrame: within 6 months
Secondary outcomes:
measure: To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake.
timeFrame: within 6 months
measure: To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)
timeFrame: within 6 months
measure: To evaluate the patient's satisfaction toward ETC
timeFrame: within 6 months
measure: To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
timeFrame: within 6 months
measure: To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
timeFrame: within 6 months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
Study officials:
affiliation: University Hospital, Bordeaux
name: Geneviève Chene, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital, Bordeaux
name: Virginie Dousset, MD
role: PRINCIPAL_INVESTIGATOR
References: