Ignite Creation Date:
2024-05-06 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05337930
Status:
WITHDRAWN
Last Update Posted:
2023-10-13
First Post:
2022-03-29
Brief Title:
Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
Sponsor:
Happyr Ltd
Organization:
Happyr Ltd
Study Overview
Official Title:
Happyr Tracking Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not enough participants enrolled in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to inform the continued development of a mobile app intended to support the treatment of CYP with migraine After extensive public and patient involvement Happyr Health has developed a mobile app that allows children and young people to track headache attacks and emotional wellbeing and to access coping techniques With the use of gamification and storytelling elements the app aims to engage children to be an active part in tracking and coping with their headaches The outcomes of this study will inform future adaptations and development cycles of the Happyr Health app
15 participants aged 10-16 will access the Happyr app for 8 weeks intervention Primary outcomes of acceptability and implementation will be measured via surveys following the 8-week intervention in the app
15 participants aged 10-16 will access the Happyr app for 8 weeks intervention Primary outcomes of acceptability and implementation will be measured via surveys following the 8-week intervention in the app
Detailed Description:
The Happyr App is a mobile app to support children and young people with primary headaches in tracking their mood and symptoms The app was developed in close collaboration with patients their parents and clinicians pediatric neurologists pediatric pain psychologists
In the Happyr Tracking study we recruit 15 CYP aged 10-16 from the neurology department at Leeds Teaching Hospitals NHS Trust Participants experience at least three primary headache attacks per month
After receiving information on the study via the Principal Investigator PI those interested can contact the research team to receive access to the Happyr App
In the app participants and their parentslegal caregivers review information on the study and give their assentconsent A copy of their signed assentconsent document will be sent to them as well as the research team and sponsor via email
After creating their account participants receive a survey in the app As soon as completed they can access the apps features Participants are asked to make an entry to their mood diary at least once per day and to their pain diary only on days they experienced a pain attack Participants are asked to send a PDF of their pain diary data which they can export in the app to the PI at the end of the intervention period 8 weeks
After 8 weeks of using the app participants will automatically receive another survey in the app to complete their participation The pain diary export can be discussed with their clinician at their next appointment
Outcomes of the study will be analyzed from the two in-app survey at beginning and end of the intervention period as well as usage data from the app analytics The study objective is to understand the acceptability and feasibility of the Happyr App
In the Happyr Tracking study we recruit 15 CYP aged 10-16 from the neurology department at Leeds Teaching Hospitals NHS Trust Participants experience at least three primary headache attacks per month
After receiving information on the study via the Principal Investigator PI those interested can contact the research team to receive access to the Happyr App
In the app participants and their parentslegal caregivers review information on the study and give their assentconsent A copy of their signed assentconsent document will be sent to them as well as the research team and sponsor via email
After creating their account participants receive a survey in the app As soon as completed they can access the apps features Participants are asked to make an entry to their mood diary at least once per day and to their pain diary only on days they experienced a pain attack Participants are asked to send a PDF of their pain diary data which they can export in the app to the PI at the end of the intervention period 8 weeks
After 8 weeks of using the app participants will automatically receive another survey in the app to complete their participation The pain diary export can be discussed with their clinician at their next appointment
Outcomes of the study will be analyzed from the two in-app survey at beginning and end of the intervention period as well as usage data from the app analytics The study objective is to understand the acceptability and feasibility of the Happyr App
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