Primary Headache DisorderNCT05337930
Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
A study testing Happyr App in people with Primary Headache Disorder, run by Happyr Ltd at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Primary Headache Disorder
- What is being tested?
- Happyr App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2022to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- With recurrent headaches (at least 3x per month)
- Access to a device (Android or iOS smartphone)
- Access to internet connection
- English-speaking
Who cannot join
- Secondary headaches
- Continuous headache
- Severe cognitive impairments
- Major comorbid medical or psychiatric illnesses (e.g. severe anxiety disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: '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.
Read the 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.
- Conditions
- Primary Headache Disorder
- Being tested
- Happyr App
- Keywords
- migraine, primary headache, tension type headache, pediatric headache, chronic pain
- Medical subject headings
- Headache Disorders, Primary, Migraine Disorders, Tension-Type Headache, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Happyr AppDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Happyr App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Post 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start4 Aug 2022
- Primary completionFeb 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Not enough participants enrolled in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Headache DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Happyr Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Munni Ray, Principal investigator, The Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337930
- Sponsor's protocol ID
- 308617
- Status last verified
- Aug 2022
- First submitted
- 29 Mar 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Happyr Tracking': Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
- ClinicalTrials.gov ID
- NCT05337930
- Acronym / sponsor ID
- 308617
- Conditions
- Primary Headache Disorder
- Keywords
- migraine, primary headache, tension type headache, pediatric headache, chronic pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not enough participants enrolled in the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Happyr LtdIndustry (pharma, biotech, devices)
- Collaborators
- The Leeds Teaching Hospitals NHS Trust
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Other | Device: Happyr AppStudy 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. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- With recurrent headaches (at least 3x per month)
- Access to a device (Android or iOS smartphone)
- Access to internet connection
- English-speaking
Key exclusion criteria (4 listed)
- Secondary headaches
- Continuous headache
- Severe cognitive impairments
- Major comorbid medical or psychiatric illnesses (e.g. severe anxiety disorder)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Happyr AppThe 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. | Device | Intervention arm |
Primary outcome
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Munni Ray principal investigator
The Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Happyr App in people with Primary Headache Disorder, run by Happyr Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)' (time frame: Post 8-week intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.