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

NCT05337930 | Withdrawn

• 1 other identifier: 308617
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Headache Disorder

Keywords

migraine; primary headache; tension type headache; pediatric headache; chronic pain

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Intervention arm

OTHER

Study participants will use the Happyr Health app, a mobile application to support CYP with primary headaches in coping with chronic pain, for eight weeks. For this study, a research version of the app will be provided via Google Play Store Testing Tracks and Apple TestFlight. In the app, a storyline and gamification elements engage CYP in filling out their headache diary and a regular mood diary.

Device: Happyr App

Interventions

Happyr App DEVICE

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.

Intervention arm

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Happyr Ltd: lead
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

The Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Headache Disorders, Primary; Migraine Disorders; Tension-Type Headache; Chronic Pain

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Munni Ray

  The Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 20, 2022
• Study Start: August 4, 2022
• Primary Completion: February 1, 2023
• Study Completion: May 1, 2023
• Last Updated: October 13, 2023

Record last verified: 2022-08

Locations

GB (1)