Skip to main content
TTrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Diagnosed cystic fibrosis - Family access to an internet-enabled device - Camera and microphone - Absence of exacerbations in the last 30 days Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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

Locations (1)

Instalaciones de la Universitat de Valencia
Valencia, Spain