MigraineCAM-ETNCT01170793
Medicine Abuse Headache
A study testing educative telephone coaching (ETC) in people with Migraine, run by University Hospital, Bordeaux at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- What is being tested?
- educative telephone coaching (ETC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Douleur Chronique - Groupe Hospitalier Pellegrin - Bât USN Tastet Girard
Bordeaux, 33076
About this study
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
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
Read the 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.
- Conditions
- Migraine
- Being tested
- educative telephone coaching (ETC)
- Keywords
- education, quality of life
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educative telephone coaching (ETC)Behavioural
a 30 to 45 minutes phone call, by appointment, by the nurse
| Study group | Role | What they receive |
|---|---|---|
| 2 | No intervention | no educative telephone coaching (ETC) |
| 1 | Experimental | with educative telephone coaching (ETC) Receives: Behavioral: educative telephone coaching (ETC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of educative telephone coaching administered by the center's nurses prior to the medical on-site visit.
Measured: 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.
Measured: within 6 months
To evaluate the efficacy of ETC on the patients quality of life and their handicap (emotional, professional and familial data)
Measured: within 6 months
To evaluate the patient's satisfaction toward ETC
Measured: within 6 months
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
Measured: within 6 months
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil
- Responsible party
- Sponsor
- Investigators
- Geneviève Chene, MD PhD, Study chair, University Hospital, BordeauxVirginie Dousset, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170793
- Sponsor's protocol ID
- CHUBX 2009/16
- Other IDs
- 2010-A00118-31
- Acronym
- CAM-ET
- Status last verified
- Dec 2012
- First submitted
- 26 Jul 2010
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01170793
- Acronym / sponsor ID
- CAM-ET / CHUBX 2009/16
- Conditions
- Migraine
- Keywords
- education, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Fondation Apicil
- Study start
- Aug 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 27 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | No intervention | –no educative telephone coaching (ETC) |
| 1 | Experimental | Behavioral: educative telephone coaching (ETC)with educative telephone coaching (ETC) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educative telephone coaching (ETC)a 30 to 45 minutes phone call, by appointment, by the nurse | Behavioural | 1 |
Primary outcome
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
5 secondary outcomes
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
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
To evaluate the patient's satisfaction toward ETC
Time frame: within 6 months
To evaluate the patient's knowledge concerning migraine, medication overuse headache and their treatment after ETC
Time frame: within 6 months
To estimate the cost/benefits ratio of ETC and its impact on medical costs ahead of the medical appointment.
Time frame: within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geneviève Chene, MD PhD study chair
University Hospital, Bordeaux
Virginie Dousset, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educative telephone coaching (ETC) in people with Migraine, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.