CAM-ET: Medicine Abuse Headache

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT01170793
Collaborator
Fondation Apicil (Other)
88
1
2
22
4

Study Details

Study Description

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
  • Behavioral: educative telephone coaching (ETC)
N/A

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

Study Type:
Interventional
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 :
Aug 1, 2010
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

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

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. [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. [within 6 months]

  2. To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data) [within 6 months]

  3. To evaluate the patient's satisfaction toward ETC [within 6 months]

  4. To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC [within 6 months]

  5. To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment. [within 6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard Bordeaux France 33076

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • Fondation Apicil

Investigators

  • Study Chair: Geneviève Chene, MD PhD, University Hospital, Bordeaux
  • Principal Investigator: Virginie Dousset, MD, UH Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01170793
Other Study ID Numbers:
  • CHUBX 2009/16
First Posted:
Jul 27, 2010
Last Update Posted:
Dec 27, 2012
Last Verified:
Dec 1, 2012
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 27, 2012