- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01170793
Medicine Abuse Headache (CAM-ET)
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33076
- Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 2
no educative telephone coaching (ETC)
|
|
|
Experimental: 1
with educative telephone coaching (ETC)
|
a 30 to 45 minutes phone call, by appointment, by the nurse
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
within 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
within 6 months
|
|
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
|
within 6 months
|
|
To evaluate the patient's satisfaction toward ETC
Time Frame: within 6 months
|
within 6 months
|
|
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
Time Frame: within 6 months
|
within 6 months
|
|
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
Time Frame: within 6 months
|
within 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Geneviève Chene, MD PhD, University Hospital, Bordeaux
- Principal Investigator: Virginie Dousset, MD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2009/16
- 2010-A00118-31 (Other Identifier: ANSM)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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