An observational study in Migraine, sponsored by Centre Hospitalier Régional Metz-Thionville. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-09.
Sponsored by Centre Hospitalier Régional Metz-Thionville · Observational
This is a real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIgraine Disability Assessment (MIDAS), Headache Impact Test short-form (HIT-6), Patient Global Impression of Change (PGIC), Hospital Anxiety and Depression (HAD) scale and Work and Personal Activities Impairment (WPAI) questionnaires at each visit.
Data describing their care will be extracted from computerized patient records.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 127 is close to the median of 130 across 299 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Centre Hospitalier Régional Metz-Thionville is the lead sponsor of 118 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Migraine [International Headache Society (IHS) criteria 2013, revised 2018] with or without aura
Exclusion Criteria:
Vascular history: myocardial infarction (MI), unstable angina or coronary bypass surgery, stroke or transient ischemic attack (TIA), Peripheral Arterial Disease of the Lower Limbs (PAD), uncontrolled hypertension
Real-life, observational, single-center cohort study to describe the efficacy of prophylactic treatment in patients after failure of at least 2 prophylactic treatments. Patients included in the study will be followed up in consultations or day hospitals according to their usual care, and will be asked to complete the MIDAS, HIT-6, PGIC, HAD and WPAI questionnaires at each visit. Data describing their care will be extracted from computerized patient records.
Headache Impact Test in patients with migraine at 12 months
Using HIT-6 (Headache Impact Test short-form) questionnaire which addresses six main domains affected by headaches, including pain, social functioning, role functioning, cognitive functioning, vitality and psychological stress. This survey is extremely useful for screening and monitoring how headaches affect patients in their day-to-day lives over time. Each item is answered on a 5-point Likert scale (6 = never, 8 = rarely, 10 = sometimes, 11 = very often, 13 = always). The scoring of the HIT-6 was derived to approximate the total score obtained from a larger battery of items, using results from item response theory (IRT) \[10\]. The final score is obtained from simple summation of the six items.
Time frame: 12 months after prophylactic treatments
Headache-related disability in patients with migraine at 12 months
MIDAS scale (Migraine Disability Assessment) measures headache-related disability and improve doctor-patient communication about the functional consequences of migraine. The questionnaire was based on five disability questions that focus on lost time in three domains: schoolwork or work for pay; household work or chores; and family, social, and leisure activities. This instrument is scored as follows: 5 to 10 indicates little or no disability, 10 to 20 indicates moderate disability, and higher than 20 denotes severe disability.
Time frame: 12 months after prophylactic treatments
Anxiety and Depression state evaluation in patients with migraine at 12 months
Using Hospital Anxiety and Depression Scale (HADS) : is a 14-item measure designed to assess anxiety and depression symptoms in medical patients, with emphasis on reducing the impact of physical illness on the total score. The depression items tend to focus on the anhedonic symptoms of depression. Items are rated on a 4-point severity scale. The HADS produces two scales, one for anxiety (HADS-A) and one for depression (HADS-D), differentiating the two states. Scores of greater than or equal to 11 on either scale indicate a definitive case.
Time frame: 12 months after prophylactic treatments
Migraine occurence in patients with migraine at 12 months
Number of migraine days
Time frame: 12 months after prophylactic treatments
Crisis treatments in patients with migraine at 12 months
Number of crisis treatments taken
Time frame: 12 months after prophylactic treatments
Patient Global Impression of Change in patients with migraine at 12 months
Using Patient Global Impression of Change (PGIC) score: a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."
Time frame: 12 months after prophylactic treatments
Work and Personal Activities Impairment in patients with migraine at 12 months
Using Work and Personal Activities Impairment (WPAI) score : a well validated instrument to measure impairments in work and activities. WPAI scores are based on 1-item (presenteeism, activitity impairment), 2-items (absenteeism) and multiple items (overall work productivity).
Time frame: 12 months after prophylactic treatments
Most Bothersome Symptom in patients with migraine at 12 months
Most Bothersome Symptom (MBS)
Time frame: 12 months after prophylactic treatments
Days off work at 12 months
Number of days off work
Time frame: 12 months after prophylactic treatments
Emergency room visits at 12 months
Number of emergency room visits
Time frame: 12 months after prophylactic treatments
Type of prophylactic treatment used at 12 months
Type of prophylactic treatment
Time frame: 12 months after prophylactic treatments
Plan to share: No
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Régional Metz-Thionville