Clinical trial NCT06958094: Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis
Official title: Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis: A 24-Week Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cystic Fibrosis (CF)
Keywords: MHealth
Gamification
Mobile App
Adherence
Engagement
Motivation
Children
Adolescent
Randomized Controlled Trial
Lead sponsor: Universidad de Córdoba
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 36
Sex: ALL
Minimum age (years): 8
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: * 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.
* Exclusion Criteria:

  * 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).

Primary outcomes:
measure: Forced Vital Capacity (FVC)
timeFrame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
measure: Forced Expiratory Volume in the first second (FEV₁)
timeFrame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
measure: Adherence to therapy
timeFrame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
measure: Health-related quality of life (HRQoL)
timeFrame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
measure: Satisfaction with the intervention
timeFrame: This outcome will be measured at three points: baseline, 12 weeks, and 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Asociación Andaluza de Fibrosis Quística
Study officials:
References: