'Happyr Tracking': Feasibility of a Developmentally-tailored Mobile App for Tracking Mood and Pain in Children With Migraine
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)'
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With recurrent headaches (at least 3x per month)
- •Access to a device (Android or iOS smartphone)
- •Access to internet connection
- •English-speaking
排除标准
- •Secondary headaches
- •Continuous headache
- •Severe cognitive impairments
- •Major comorbid medical or psychiatric illnesses (e.g. severe anxiety disorder)
结局指标
主要结局
Acceptability Modified 'The mHealth App Usability Questionnaire (MAUQ)'
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点