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

Not Applicable
Recruiting
Conditions
Cystic Fibrosis
Registration Number
NCT06313827
Lead Sponsor
University of Valencia
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
60
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Clinical exacerbationAt 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 Outcome Measures
NameTimeMethod
OxigenationAt baseline (T1), at 6 months (T2) and at 12 months(T3).

Oxyhemoglobin saturation in percent.

Functional capacityAt baseline (T1), at 6 months (T2) and at 12 months(T3).

30 seconds sit-to-stand test (in number of repetitions)

Spirometric functionAt baseline (T1), at 6 months (T2) and at 12 months(T3).

Forced expiratory volume in the first second (FEV1) in L/sec

DyspneaAt baseline (T1), at 6 months (T2) and at 12 months(T3).

Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea.

Quality of life (QoL)At baseline (T1) and at 12 months(T3).

Cystic fibrosis questionnaire-revised (in score points). It is a 0-100 scale with higher scores indicating better quality of life.

Trial Locations

Locations (1)

Instalaciones de la Universitat de Valencia

🇪🇸

Valencia, Spain

Instalaciones de la Universitat de Valencia
🇪🇸Valencia, Spain
Francisco Martinez Arnau, PhD
Contact
Anna Arnal Gomez, PhD
Sub Investigator
Sara Cortes Amador, PhD
Principal Investigator
Francisco Martínez Arnau, PhD
Sub Investigator
Carlos Gomez Chinesta, PT
Sub Investigator

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