NCT06313827

e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population

Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Valencia · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life. Participants will be assigned to one of 3 study groups: Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
BEHAVIORAL	Exercise plus Monitoring Group (TG-2)	Participants will receive their usual physiotherapy treatment and user education on bronchial care and hygiene, plus a dossier on the use of monitoring equipment such as: pulse oximeter, thermometer, digital spirometer, Medical Research Council dyspnoea scale. If the patient detects an exacerbation (due to symptoms or monitoring of the equipment), they can contact a physiotherapist who can adjust the treatment.
BEHAVIORAL	Exercise plus monitoring and follow-up group (TGF-3)	Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene, plus dossiers on the use of monitoring equipment ; plus telematic control of exacerbations (questionnaires and monitoring of the parameters of the aforementioned equipment). Depending on the follow-up, physiotherapy treatment will be adjusted. The questionnaire includes tracking of the following parameters: cough, secretions (quantity, colour, viscosity), chest tightness, dyspnoea, exercise tolerance, tiredness and appetite). The follow-up will consist of weekly filling the spreadsheet to which the physiotherapist will have access and who, by reviewing the parameters, will be able to adjust the treatment. The physiotherapist will systematically make videocalls to the participants and if the follow-up values require it, he/she will call every week.
BEHAVIORAL	Exercise Group (CG-1)	Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-01-01
• Completion: 2027-01-01
• First posted: 2024-03-15
• Last updated: 2025-02-13

Locations

1 site across 1 country: Spain