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Medicine Abuse Headache (CAM-ET)

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
educative telephone coaching (ETC)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Migraine focused on measuring education, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

2

1

Arm Description

no educative telephone coaching (ETC)

with educative telephone coaching (ETC)

Outcomes

Primary Outcome Measures

To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.

Secondary Outcome Measures

To evaluate the efficacy of educative telephone coaching (ETC) on the frequency of headaches and on the number of days with crisis treatment intake.
To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)
To evaluate the patient's satisfaction toward ETC
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.

Full Information

First Posted
July 26, 2010
Last Updated
December 26, 2012
Sponsor
University Hospital, Bordeaux
Collaborators
Fondation Apicil
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1. Study Identification

Unique Protocol Identification Number
NCT01170793
Brief Title
Medicine Abuse Headache
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
Fondation Apicil

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
education, quality of life

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
No Intervention
Arm Description
no educative telephone coaching (ETC)
Arm Title
1
Arm Type
Experimental
Arm Description
with educative telephone coaching (ETC)
Intervention Type
Behavioral
Intervention Name(s)
educative telephone coaching (ETC)
Intervention Description
a 30 to 45 minutes phone call, by appointment, by the nurse
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
To evaluate the patient's satisfaction toward ETC
Time Frame
within 6 months
Title
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
Time Frame
within 6 months
Title
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
Time Frame
within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geneviève Chene, MD PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Virginie Dousset, MD
Organizational Affiliation
UH Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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Medicine Abuse Headache

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