Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis: A 24-Week Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Forced Vital Capacity (FVC)
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate the effectiveness of gamified mobile health (mHealth) applications for airway clearance therapy in children and adolescents with cystic fibrosis. Primary outcomes include Forced Vital Capacity (FVC), Forced Expiratory Volume in the first second (FEV₁), adherence to therapy, health-related quality of life (HRQoL), and satisfaction with the intervention. The intervention will consist of 20-minute sessions, performed twice daily over a 24-week period. At least a total of 36 participants aged 8 to 18 years with cystic fibrosis will be randomly assigned to three equally sized groups: the experimental group (gamified mHealth apps: Voice Volume Catcher, Scream Go Hero, and Chicken Scream), the control group (conventional airway clearance techniques: Autogenic Drainage, Active Cycle of Breathing Techniques, and Positive Expiratory Pressure therapy), and the mixed group (10 minutes of gamified mHealth apps combined with 10 minutes of conventional techniques). This study seeks to provide evidence on the feasibility and clinical benefits of integrating gamification into airway clearance therapy to improve respiratory outcomes and patient engagement in pediatric cystic fibrosis care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Population with cystic fibrosis (CF), aged 8-20 years.
- •Individuals using or not using CFTR modulators (e.g., Kaftrio, Kalydeco, etc.), regardless of their specific mutation.
排除标准
- •Forced Vital Capacity (FVC) and/or Forced Expiratory Volume in the first second (FEV1) < 40%.
- •Oxygen therapy or continuous mechanical ventilation.
- •Moderate hemoptysis or recent pneumothorax (within the past 3 months).
- •Presence of an active, uncontrolled respiratory infection exacerbation that required hospitalization within the 30 days prior to the intervention.
- •Other conditions such as neuromuscular disorders or cognitive difficulties (Mini-Mental State Examination score < 19 points).
研究组 & 干预措施
Experimental Group
At least twelve participants will engage in airway clearance therapy using gamified mobile health (mHealth) applications. These apps are designed to promote the control of sound intensity during open-glottis expiratory maneuvers, utilizing the smartphone's integrated microphone to detect vocal output. The sound generated during breathing reflects active respiratory effort and effective glottic control, supporting secretion mobilization and enhancing airway clearance efficacy.
干预措施: Gamified mobile health applications (Other)
Control Group
At least twelve participants will undergo treatment with conventional airway clearance techniques. These techniques are designed to promote effective secretion mobilization and improve lung function. Participants will be guided through a series of controlled breathing exercises aimed at optimizing airflow and enhancing secretion clearance. These methods involve active participation to perform specific maneuvers that facilitate the removal of mucus from the airways, improving overall respiratory function.
干预措施: Conventional Airway Clearance Therapy (Other)
Mixed Intervention Group
At least twelve participants will undergo a combined intervention, consisting of 10 minutes of gamified mHealth app use followed by 10 minutes of conventional airway clearance techniques, or the sequence may be reversed. This dual approach will enable participants to benefit from both interactive digital engagement and established respiratory therapies, optimizing mucus clearance and enhancing overall pulmonary function.
干预措施: Combination Treatment (Other)
结局指标
主要结局
Forced Vital Capacity (FVC)
时间窗: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Total volume of air that can be forcibly exhaled after a full inhalation. It is a key parameter measured during spirometry testing to assess lung function.
Forced Expiratory Volume in the first second (FEV₁)
时间窗: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The volume of air exhaled during the first second of a forced exhalation after a full inhalation. It is a key parameter measured during spirometry testing to assess airflow and diagnose respiratory conditions.
Adherence to therapy
时间窗: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The extent to which participants follow the prescribed therapeutic regimen. Adherence will be assessed over time using the gamified mHealth app (experimental group), a stopwatch application (control group), or a combination of both (mixed intervention group), all monitored through the StayFree app.
Health-related quality of life (HRQoL)
时间窗: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
This measure will evaluate the impact of cystic fibrosis on participants' daily lives, including physical, emotional, and social well-being. The age-adapted Cystic Fibrosis Questionnaire-Revised (CFQ-R) will be used. The CFQ-R scores range from 0 to 100, with higher scores indicating better health-related quality of life. Cut-off points may vary depending on the study's context, but scores below 50 are often interpreted as indicating significant impairment in quality of life.
Satisfaction with the intervention
时间窗: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
The outcome will be assessed using the Treatment Satisfaction Questionnaire for Medication (TSQM), adapted for a physical therapy intervention. This tool will measure participants' contentment with the therapy and their overall treatment experience. The TSQM scores range from 0 to 100 for each domain (effectiveness, side effects, convenience, and global satisfaction), with higher scores indicating greater satisfaction. There are no universally established cut-off points, but higher scores typically reflect more positive treatment experiences.
次要结局
未报告次要终点
研究者
Alvaro Alba Rueda
Prof
Universidad de Córdoba