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Medicine Abuse Headache (CAM-ET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170793
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : December 27, 2012
Sponsor:
Collaborator:
Fondation Apicil
Information provided by (Responsible Party):
University Hospital, Bordeaux

Study Description
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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

Condition or disease Intervention/treatment Phase
Migraine Behavioral: educative telephone coaching (ETC) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Headache

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To evaluate the patient's satisfaction toward ETC [ Time Frame: within 6 months ]
  4. To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC [ Time Frame: within 6 months ]
  5. To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment. [ Time Frame: within 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170793


Locations
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France
Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Fondation Apicil
Investigators
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Study Chair: Geneviève Chene, MD PhD University Hospital, Bordeaux
Principal Investigator: Virginie Dousset, MD UH Bordeaux
More Information
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01170793    
Other Study ID Numbers: CHUBX 2009/16
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: December 2012
Keywords provided by University Hospital, Bordeaux:
education, quality of life
Additional relevant MeSH terms:
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Headache
Pain
Neurologic Manifestations