Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine

Primary Headache Disorder Clinical Trial

Official title:

'Happyr Tracking': Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05337930
• Other study ID #: 308617
• Status: Withdrawn
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: May 2023

Study information

• Verified date: August 2022
• Source: Happyr Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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)

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Headache Disorders, Primary
• Migraine Disorders
• Primary Headache Disorder

Intervention

Device:
• Happyr App
The Happyr app offers three main areas: (A) A mood diary in which a user can keep track of emotional wellbeing by answering three short questions. (B) A pain diary in which a user and supporter can record headache attacks by answering a set of predefined questions whenever a user experiences or has experienced a headache attack. (C) An overview section in which entries from the mood and pain diary are visualized for the user. In this section, a PDF document can also be exported with a summary of data from the symptom diary that can be taken to the clinician. A standardized notification is sent to each user at 6pm local time to remind them about logging their mood and symptoms of a headache attack.

Locations

Country	Name	City	State
United Kingdom	The Leeds Teaching Hospitals NHS Trust	Leeds

Sponsors (2)

Lead Sponsor	Collaborator
Happyr Ltd	The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)'	Acceptability of the app to patients will be measured using items adapted from the mHealth App Usability Questionnaire. Questions use a Likert agreement response scale. A higher total score reflects greater acceptability (1 = strongly disagree (worse outcome); 5 = strongly agree (better outcome)). Our selected threshold for defining adequate acceptability is that 80% of participants will have an average score of at least 4/5 on the acceptability questionnaire (indicating moderate to high satisfaction with the app). Participants also will be asked in an open-ended item to provide general comments about their experience with the app.	Post 8-week intervention
Primary	Implementation (App usage frequency)	Implementation will be evaluated using app analytics to measure the frequency of making a mood diary entry per week. Our selected threshold for defining acceptable implementation is that 80% of participants will submit an average of at least 4 completed daily diaries per week over the course of 8 weeks.	Post 8-week intervention