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

Sponsor
University of Valencia
Study ID
NCT06313827
Status
Recruiting
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Conditions

  • Cystic Fibrosis

Eligibility Criteria

Sex
ALL
Age
6 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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

Study Details

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.

Key Dates

First listed
Mar 15, 2024
Start date
Oct 1, 2024
Status verified
Feb 2025
Primary completion
Jan 31, 2026
Completion
Jan 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Control exercise group (CG-1)
    Participants will receive their usual physiotherapy treatment.
  • Experimental: Exercise plus monitoring group (TG-2)
    Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.
  • 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.

Primary Outcome Measure

Clinical exacerbation [ Time Frame: At baseline (T1), at 6 months (T2) and at 12 months(T3). ]

Central Contacts

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