Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:08 PM
Study NCT ID:
NCT06958094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-08
First Post:
2025-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Gamified Mobile Health Apps for Airway Clearance Therapy in Children and Adolescents With Cystic Fibrosis
Sponsor:
Universidad de Córdoba
Organization:
Study Overview
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.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EGmACT-CF
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: