Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cystic Fibrosis
- Sponsor
- University of Valencia
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical exacerbation
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
SARA CORTES AMADOR
Assistant lecturer PhD in Physiotherapy
University of Valencia
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
- •Cognitive problems that make it impossible for them to use telematic devices.
Outcomes
Primary Outcomes
Clinical exacerbation
Time Frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Presence of an exacerbation. To consider this the Escribano criteria will be followed, for which the presence of at least 3 of the criteria stablished (Clinical, spirometric, radiographic, analytical, and microbiological), collected by interviewing the patient
Secondary Outcomes
- Oxigenation(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Functional capacity(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Spirometric function(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Dyspnea(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Quality of life (QoL)(At baseline (T1) and at 12 months(T3).)