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

October 12, 2023 updated by: Happyr Ltd

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Leeds, United Kingdom
        • The Leeds Teaching Hospitals NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 14 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention arm
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)'
Time Frame: Post 8-week intervention
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)
Time Frame: Post 8-week intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Happyr Ltd

Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

  • Principal Investigator: Munni Ray, The Leeds Teaching Hospitals NHS Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 4, 2022

Primary Completion (Estimated)

February 1, 2023

Study Completion (Estimated)

May 1, 2023

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 308617

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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