Actively Recruiting
Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
Led by University of Valencia · Updated on 2025-02-13
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of Valencia
Lead Sponsor
A
Asociación de Fibrosis Quística - Comunidad Valenciana
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an e-Health program designed to help people with cystic fibrosis by identifying lung exacerbations early. This trial aims to prevent lung function loss and maintain quality of life through a telematic assessment and monitoring protocol. Participants will be randomly assigned to one of three groups to compare usual physiotherapy alone, physiotherapy plus monitoring education, or physiotherapy plus monitoring and telematic follow-up with physiotherapist feedback. The three groups include a control group receiving their usual physiotherapy treatment; a treatment group receiving physiotherapy plus education on how to use monitoring devices like a pulse oximeter, thermometer, digital spirometer, and a dyspnoea scale; and a treatment and follow-up group that receives physiotherapy, monitoring education, and weekly telematic control of symptoms and physiological parameters through questionnaires and monitoring equipment. This last group also gets regular video calls from a physiotherapist who can adjust treatment based on the collected data. Participants will be assessed at baseline, 6 months, and 12 months for clinical exacerbations, breathing difficulty, lung function, oxygenation, physical capacity, and quality of life. They will monitor symptoms weekly and provide data through digital tools, which helps the physiotherapist tailor care. The study lasts at least one year, with detailed follow-up to understand how telematic support affects health management and outcomes in cystic fibrosis.
CONDITIONS
Brief Title
e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed cystic fibrosis
- Family access to an internet-enabled device with camera and microphone
- No lung exacerbations in the last 30 days
You will not qualify if you...
- Lung transplant recipients or patients on the waiting list for lung transplantation
- Eye surgery within the last 3 months
- Hemothorax
- Active infection or inflammatory process
- Tumors
- Cognitive problems preventing use of telematic devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive usual physiotherapy treatment and user education on bronchial care and hygiene. Depending on the group, participants may also use monitoring equipment and have telematic control with physiotherapist feedback.
Regular interactions via teleconferencing and weekly monitoring for some groups
Duration - 12 months
Participants are assessed for clinical exacerbations, lung function, dyspnea, oxygenation, functional capacity, and quality of life at baseline, 6 months, and 12 months.
3 visits (in-person) at baseline, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Instalaciones de la Universitat de Valencia
Valencia, Spain, 46010
Actively Recruiting
Research Team
F
Francisco Martinez-Arnau, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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