NCT01170793

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

December 27, 2012

Status Verified

December 1, 2012

Enrollment Period

1.8 years

First QC Date

July 26, 2010

Last Update Submit

December 26, 2012

Conditions

Keywords

education, quality of life

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 INTERVENTION

no educative telephone coaching (ETC)

1

EXPERIMENTAL

with educative telephone coaching (ETC)

Behavioral: educative telephone coaching (ETC)

Interventions

a 30 to 45 minutes phone call, by appointment, by the nurse

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

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

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Geneviève Chene, MD PhD

    University Hospital, Bordeaux

    STUDY CHAIR
  • Virginie Dousset, MD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

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

Locations