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Recruiting NCT06313827

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

No phase Interventional Cystic Fibrosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Exercise plus Monitoring Group (TG-2), Exercise plus monitoring and follow-up group (TGF-3), Exercise Group (CG-1).
Who it may be relevant to
Registry conditions: Cystic Fibrosis. Basic parameters: from 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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
  • Behavioral Exercise Group (CG-1)
    Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene

Primary outcome measures

  • Clinical exacerbation [Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
Secondary outcome measures (5)
  • Dyspnea [Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
  • Spirometric function [Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
  • Oxigenation [Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
  • Functional capacity [Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
  • Quality of life (QoL) [Time frame: At baseline (T1) and at 12 months(T3).]

Eligibility criteria

Inclusion criteria

  • Diagnosed cystic fibrosis
  • Family access to an internet-enabled device
  • Camera and microphone
  • Absence of exacerbations in the last 30 days

Exclusion criteria

  • Patients with lung transplant or on the waiting list for lung transplantation
  • Previous eye surgery (3 months)
  • Hemothorax
  • Active infection or inflammatory process
  • Tumors
  • Cognitive problems that make it impossible for them to use telematic devices.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Instalaciones de la Universitat de Valencia — Valencia

Identifiers

NCT: NCT06313827 · UV-INV_3165929

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗