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

February 11, 2025 updated by: SARA CORTES AMADOR, University of Valencia

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Recruiting
        • Instalaciones de la Universitat de Valencia
        • Contact:
          • Francisco Martinez Arnau, PhD
        • Sub-Investigator:
          • Anna Arnal Gomez, PhD
        • Principal Investigator:
          • Sara Cortes Amador, PhD
        • Sub-Investigator:
          • Francisco Martínez Arnau, PhD
        • Sub-Investigator:
          • Carlos Gomez Chinesta, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control exercise group (CG-1)
Participants will receive their usual physiotherapy treatment.
Behavioral: Exercise Group (CG-1)
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene
Other Names:
  • Exercise Group
Experimental: Exercise plus monitoring group (TG-2)
Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.
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.
Other Names:
  • Exercise plus Monitoring Group
Experimental: Exercise plus monitoring and follow-up group (TGF-3)
Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control (via 1:1 real-time videoconferencing) of exacerbations with feedback from the physiotherapist.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline (T1), at 6 months (T2) and at 12 months(T3).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (T1), at 6 months (T2) and at 12 months(T3).
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
At baseline (T1), at 6 months (T2) and at 12 months(T3).
Oxigenation
Time Frame: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Oxyhemoglobin saturation in percent.
At baseline (T1), at 6 months (T2) and at 12 months(T3).
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)
At baseline (T1), at 6 months (T2) and at 12 months(T3).
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.
At baseline (T1) and at 12 months(T3).

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline (T1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Asociación de Fibrosis Quística - Comunidad Valenciana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

March 1, 2024

First Submitted That Met QC Criteria

March 12, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UV-INV_3165929

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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