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
1 other identifier
interventional
88
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2010
CompletedFirst Posted
Study publicly available on registry
July 27, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedDecember 27, 2012
December 1, 2012
1.8 years
July 26, 2010
December 26, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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 Outcomes (5)
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
To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)
within 6 months
To evaluate the patient's satisfaction toward ETC
within 6 months
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
within 6 months
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
within 6 months
Study Arms (2)
2
NO INTERVENTIONno educative telephone coaching (ETC)
1
EXPERIMENTALwith educative telephone coaching (ETC)
Interventions
a 30 to 45 minutes phone call, by appointment, by the nurse
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Fondation Apicilcollaborator
Study Sites (1)
Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
Bordeaux, 33076, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Geneviève Chene, MD PhD
University Hospital, Bordeaux
- PRINCIPAL INVESTIGATOR
Virginie Dousset, MD
University Hospital, Bordeaux
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2010
First Posted
July 27, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
December 27, 2012
Record last verified: 2012-12