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

NCT06313827 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-02-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Asociación de Fibrosis Quística - Comunidad Valenciana

    collaborator UNKNOWN

  • University of Valencia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2026-01-31
Completion
2027-01-31

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06313827 on ClinicalTrials.gov