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Educational Intervention in Patients With Migraine (M01)

Primary Purpose

Migraine

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Educational programme
Routine clinical practice
Sponsored by
Basque Health Service
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine disorders, Educational models, Neuroscience

Eligibility Criteria

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

Inclusion Criteria:

  • Belong to one of these health centres of primary care: San Martín, Sansomendi, Lakuarriaga, Gazalbide and Zabalgana,
  • Diagnosed with migraine (ICD-9-CM Diagnosis Code 346) who had at least one migraine attack every month despite treatment.

Exclusion Criteria:

  • We excluded patients with mental illness, cognitive impairment or language deficits that might hinder completion of follow-up and patients that would not be able to attend to all the sessions of the intervention or had received training as part of the previous pilot study.

Sites / Locations

  • Iñaki Aguirrezabal Bazterrica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.

Routine clinical practice

Outcomes

Primary Outcome Measures

Migraine-related disability given by the MIDAS score
The sum of responses to five questions on days missed or with reduced productivity at work/school, at home and in leisure activities.I If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.

Secondary Outcome Measures

Intensity and frequency of the pain
Measured using the two supplementary questions of the MIDAS, the two supplementary questions of the MIDAS. If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.
Degree to which activities of daily life were limited by migraine
Measured using an ad hoc scale with six possible answers: not at all, very little, little, quite a lot, a lot, and totally.
costs associated with migraine-related treatment
Both preventive medication and medication for treating migraine attacks

Full Information

First Posted
December 14, 2017
Last Updated
December 21, 2017
Sponsor
Basque Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT03381924
Brief Title
Educational Intervention in Patients With Migraine
Acronym
M01
Official Title
Effectiveness of a Group Educational Intervention in Patients With Migraine: a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 1, 2013 (Actual)
Primary Completion Date
May 30, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Basque Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Introduction: Despite the numerous pharmacological treatment options available for migraine attacks and for the prevention of thereof, less than 30% of patients with migraine are highly satisfied with their current treatment. In recent decades, there has been a radical change in the way we view pain, thanks to developments in neuroscience. It is currently considered that pain does not originate in the peripheral nociceptors, but rather in a network of brain regions (the pain neuromatrix), the synchronous activation of which is necessary and sufficient to generate the perception of pain. Migraine may be the expression of this exaggerated perception of threat, a perception that, from a cultural learning perspective, it may be possible to modify by adjusting beliefs and behaviours that favour the onset of an attack. The aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of Alava.
Detailed Description
The aim of this study was to assess the effectiveness of a group educational intervention about concepts of pain neuroscience, in the management of migraine, compared to routine medical interventions, in primary care health centres of Alava. After recruitment, patients were interviewed by the research team members in charge of the assessments. In these interviews, data were collected on the following: demographic characteristics, beliefs regarding migraine, coping strategies for migraine attacks, the MIDAS questionnaire (16), medication taken, work leave, emergency department attendances and limitation of daily activities due to migraine, during the previous 3 months. Subsequently, we carried out further assessments over the telephone after 3, 6 and 12 months. Very few studies assessing preventive treatments for migraine have performed assessments 12 months after initiating prophylactic treatment, most having followed-up patients for 6 months at most. We believe, however, it is necessary to continue assessments for at least 1 year to properly test the efficacy of treatment for chronic illnesses like migraine. The individuals carrying out the assessment were blinded to group allocation. The clinical follow-up was the same for both groups, the only difference in their management being the educational intervention itself.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine disorders, Educational models, Neuroscience

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Routine clinical practice
Intervention Type
Other
Intervention Name(s)
Educational programme
Intervention Description
In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
Intervention Type
Other
Intervention Name(s)
Routine clinical practice
Intervention Description
Patients allocated to the control group will only receive the drugs used in the habitual clinical practice
Primary Outcome Measure Information:
Title
Migraine-related disability given by the MIDAS score
Description
The sum of responses to five questions on days missed or with reduced productivity at work/school, at home and in leisure activities.I If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Intensity and frequency of the pain
Description
Measured using the two supplementary questions of the MIDAS, the two supplementary questions of the MIDAS. If patients has reduced the score in MIDAS scale by at least the 50% of the baseline score, we consider that the patient has responded to the treatment.
Time Frame
12 months
Title
Degree to which activities of daily life were limited by migraine
Description
Measured using an ad hoc scale with six possible answers: not at all, very little, little, quite a lot, a lot, and totally.
Time Frame
12 months
Title
costs associated with migraine-related treatment
Description
Both preventive medication and medication for treating migraine attacks
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Belong to one of these health centres of primary care: San Martín, Sansomendi, Lakuarriaga, Gazalbide and Zabalgana, Diagnosed with migraine (ICD-9-CM Diagnosis Code 346) who had at least one migraine attack every month despite treatment. Exclusion Criteria: We excluded patients with mental illness, cognitive impairment or language deficits that might hinder completion of follow-up and patients that would not be able to attend to all the sessions of the intervention or had received training as part of the previous pilot study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
IÑAKI AGUIRREZABAL
Organizational Affiliation
Basque Health Service
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iñaki Aguirrezabal Bazterrica
City
Vitoria-gasteiz
State/Province
Alava
Country
Spain

12. IPD Sharing Statement

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Educational Intervention in Patients With Migraine

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