Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06180577
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-12
Brief Title:
A Survey Study to Assess the Accessibility of the Nerivio Device at School
Sponsor:
Theranica
Organization:
Theranica
Study Overview
Official Title:
A Retrospective Survey Study to Assess the Accessibility Preference and Frequency of Adolescents Using Nerivio in School Setting
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a retrospective survey-study to assess the accessibility preference and frequency of adolescents using Nerivio by itself in combination with pharmacological medications or not at all in the school setting The study population is prescribed Nerivio users under the age of 18 years old who have used the Nerivio device at least once The study will be conducted electronically and will include eligibility questions an electronic informed consent form signed by the parentlegal guardian e-ICF an assent form signed by the adolescent patient e-Assent and an e-survey relating to the management of headaches due to migraine attacks Participants will be recruited from Nerivios userbase and will be compensated for their participation
Detailed Description:
This is a retrospective survey-study to assess the accessibility preference and frequency of adolescents using Nerivio by itself in combination with pharmacological medications or not at all in the school setting The study population is prescribed Nerivio users under the age of 18 years old who have used the Nerivio device at least once
Study group Participants will be recruited from Nerivios user database An invitation message will be sent via emails andor in-app notifications to Nerivio users who are 1 under the age of 18 years old and 2 treated with Nerivio at least once Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility
Adolescents who are found eligible will be offered the opportunity to participate in the study If they are willing they will first be directed to an Informed Consent Form e-ICF to be signed by the participants parentlegal guardian A copy of the completed form will be automatically sent to the parentlegal guardian upon completion If the parentlegal guardian consents via the e-ICF to hisher childs participation an electronic assent form will follow and must be signed by the adolescent patient A copy of the assent form will be automatically sent to the parents and the adolescent patient Once both electronic consent forms are signed the adolescent patient will be enrolled in the study and will be directed to the study survey
Primary outcome measures
Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone relative to other options combination pharmaceutical not treating while in school
Secondary outcome measures
1 - Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school including the need to leave class for treatment lack of availability of treatments while at school and time delay to treat headaches
2 - Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio specific pharmaceutical agents or not treating at all reflecting convergence to using Nerivio at school
Study group Participants will be recruited from Nerivios user database An invitation message will be sent via emails andor in-app notifications to Nerivio users who are 1 under the age of 18 years old and 2 treated with Nerivio at least once Adolescents who meet these criteria will be invited to answer a screening questionnaire verifying eligibility
Adolescents who are found eligible will be offered the opportunity to participate in the study If they are willing they will first be directed to an Informed Consent Form e-ICF to be signed by the participants parentlegal guardian A copy of the completed form will be automatically sent to the parentlegal guardian upon completion If the parentlegal guardian consents via the e-ICF to hisher childs participation an electronic assent form will follow and must be signed by the adolescent patient A copy of the assent form will be automatically sent to the parents and the adolescent patient Once both electronic consent forms are signed the adolescent patient will be enrolled in the study and will be directed to the study survey
Primary outcome measures
Percent of adolescents who prefer treating headaches due to migraine when they are at school with Nerivio alone relative to other options combination pharmaceutical not treating while in school
Secondary outcome measures
1 - Distribution of barriers to adolescents who report the necessity to treat their headaches due to migraine while at school including the need to leave class for treatment lack of availability of treatments while at school and time delay to treat headaches
2 - Distribution of treatments used by adolescents at school to treat migraine headaches prior to being prescribed Nerivio specific pharmaceutical agents or not treating at all reflecting convergence to using Nerivio at school
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None