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

NCT06313827 | Recruiting

• 1 other identifier: UV-INV_3165929
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

e-Health; physiotherapy; Cystic fibrosis; exacerbation; quality of life

Outcome Measures

Primary Outcomes (1)

• Clinical exacerbation

  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 Outcomes (5)

• Dyspnea

  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).

• 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).

• Quality of life (QoL)

  At baseline (T1) and at 12 months(T3).

Other Outcomes (1)

• Motivation to engage in physical activity

  At baseline (T1)

Study Arms (3)

Control exercise group (CG-1)

ACTIVE COMPARATOR

Participants will receive their usual physiotherapy treatment.

Behavioral: Exercise Group (CG-1)

Exercise plus monitoring group (TG-2)

EXPERIMENTAL

Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.

Behavioral: Exercise plus Monitoring Group (TG-2)

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

EXPERIMENTAL

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)

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.

Also known as: Exercise plus Monitoring Group

Exercise plus monitoring group (TG-2)

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

Exercise Group (CG-1) BEHAVIORAL

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

Also known as: Exercise Group

Control exercise group (CG-1)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed cystic fibrosis
• Family access to an internet-enabled device
• Camera and microphone
• Absence of exacerbations in the last 30 days

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Asociación de Fibrosis Quística - Comunidad Valenciana: collaborator

Study Sites (1)

Instalaciones de la Universitat de Valencia

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Exercise; KTN1 protein, human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Francisco Martinez-Arnau, PhD

CONTACT

0034963983853; francisco.m.martinez@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to one of three study groups by the person conducting the intervention. All participants receive usual physiotherapy treatment, and both intervention groups receive monitoring and follow-up of their clinical situation. The evaluators are unaware of the assignment at all times.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer PhD in Physiotherapy

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 15, 2024
• Study Start: October 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)