Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06313827

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instalaciones de la Universitat de Valencia

Valencia, 46010, Spain

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise plus Monitoring Group (TG-2)

Behavioral

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.

Other names: Exercise plus Monitoring Group

Exercise plus monitoring and follow-up group (TGF-3)

Behavioral

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.

Exercise Group (CG-1)

Behavioral

Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene

Other names: Exercise Group

Primary outcomes

  1. 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

  1. Dyspnea

    Time frame: At 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.

  2. Spirometric function

    Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).

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

  3. Oxigenation

    Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).

    Oxyhemoglobin saturation in percent.

  4. Functional capacity

    Time frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).

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

  5. Quality of life (QoL)

    Time frame: 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.

Other outcomes

  1. Motivation to engage in physical activity

    Time frame: At baseline (T1)

    A confidential online ad-hoc 13-item survey regarding their views, opinions and practices in relation to physical activity. This is a survey that is analyzed qualitatively.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Asociación de Fibrosis Quística - Comunidad Valenciana

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Mar 15, 2024
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.