To evaluate the reduction of emotional burden (measured by Relative Stress Scale-RSS) of caregivers of migraine patients with Depressive Symptoms after 6 months after the first injection of fremanezumab.
Study Type
OBSERVATIONAL
Enrollment
308
subcutaneous injection 225 mg monthly or 675 mg quarterly
Fondazione Policlinico Universitario Campus Bio-Medico
Rome, Italy, Italy
Ospedali Riuniti "Umberto I"- GM LANCISI G.SALESI
Ancona, Italy
PO Avezzano "S.Filippo e Nicola"
Avezzano, Italy
Clinica Neurologica "L. Amaducci" Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy
IRCCS Istituto Scienze Neurologiche
Bologna, Italy
ASST Spedali Civili Brescia
Brescia, Italy
Fondazione IRCCS Istituto Neurologico "Carlo Besta
Milan, Italy
Dipartimento delle scienze avanzate mediche e chirurgiche, Università della Campania "Luigi Vanvitelli
Naples, Italy
IRCCS San Raffaele Pisana
Rome, Italy
Ospedale Fabenefratelli- San Pietro
Rome, Italy
CHANGE in caregiver stress
Change in Relative Stress Scale (RSS) scores in caregivers (range 15-60, where 15 is no stress and 60 maximum stress)
Time frame: from baseline to evaluation at 6 months of fremanezumab therapy
CHANGE IN RECIPROCITY
To evaluate an increase in reciprocity within the mutuality scale in the caregiver/ migraine patient dyad after 6 months from the first injection of fremanezumab. Reciprocity represents the mean value of the response to questions 5, 6, 10, 13, and 15 of the mutuality scale (raging from 0, lower reciprocity, to 4 higher reciprocity)
Time frame: from baseline to the evaluation at 6 months of therapy with fremanezumab
CORRELATION BETWEEN CHANGE IN patient depression and caregiver stress
to evaluate whether the change in depression (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers.
Time frame: from baseline to 6 months after fremanezumab therapy
CORRELATION BETWEEN THE CHANGES IN DEPRESSION AND RECIPROCITY SCALE SCORES
To evaluate whether the CHANGE in depressive (Patient Health Questionnaire. PHQ-9 scores, range 0-27; higher scores indicate more severe depression) and anxiety (STATE-TRAIT ANXIETY INVENTORY STAY, range 20-80, from 40 points to higher scores indicate anxiety) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change in reciprocity (MUTUALITY SCALE, range 0-4 higher score inficate higher mutuality) between patient and caregiver
Time frame: from baseline to 6 months after therapy with fremanezumab
PATIENT ANXIETY AND CAREGIVER STRESS
to evaluate whether the change in anxiety (STATE-TRAIT ANXIETY INVENTORY STAY, range 20-80, from 40 points to higher scores indicate anxiety) symptoms in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers
Time frame: from baseline to 6 months after fremanezumab therapy
PATIENT DISABILTY AMD CAREGIVER STRESS
to evaluate whether the change in anxiety disability (MiGRAINE DISABILITY ASSESSMENT MIDAS raging from 0 to 270, higher scores indicate greater disability) in migraine patients 6 months after starting fremanezumab is associated with the change of stress (Relative Stress Scale) in caregivers
Time frame: from baseline to 6 months after fremanezumab therapy
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