Clinical trial NCT05337930: Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
Official title: 'Happyr Tracking': Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary Headache Disorder
Keywords: migraine
primary headache
tension type headache
pediatric headache
chronic pain
Lead sponsor: Happyr Ltd
Sponsor class: INDUSTRY
Collaborators: name: The Leeds Teaching Hospitals NHS Trust
First posted: 2022-04-20
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 parents/legal caregivers review information on the study and give their assent/consent. A copy of their signed assent/consent 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 app's 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.

Eligibility criteria: Inclusion Criteria:

* With recurrent headaches (at least 3x per month)
* Access to a device (Android or iOS smartphone)
* Access to internet connection
* English-speaking

Exclusion Criteria:

* Secondary headaches
* Continuous headache
* Severe cognitive impairments
* Major comorbid medical or psychiatric illnesses (e.g. severe anxiety disorder)

Primary outcomes:
measure: Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)'
timeFrame: Post 8-week intervention
measure: Implementation (App usage frequency)
timeFrame: Post 8-week intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: The Leeds Teaching Hospitals NHS Trust
Study officials:
affiliation: The Leeds Teaching Hospitals NHS Trust
name: Munni Ray
role: PRINCIPAL_INVESTIGATOR
References: