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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Home Monitoring to Predict Exacerbation in Cystic Fibrosis

NCT02416375

Cystic Fibrosis

COMPLETED

Early Intervention in Pulmonary Exacerbation in Cystic Fibrosis

NCT00850551

Cystic Fibrosis

COMPLETED NA

Effects of an Individualized Exercise Program on Health-related and Skill/Performance-related ﬁtness in CF.

NCT03518697

Cystic Fibrosis

COMPLETED NA

Video Telehealth Exercise Training in Cystic Fibrosis

NCT04680403

Cystic Fibrosis

COMPLETED NA

Pilot Trial of ExACT (Exercise as Airway Clearance Therapy) for People With Cystic Fibrosis

NCT05482048

Cystic Fibrosis

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cystic Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control exercise group (CG-1)

Participants will receive their usual physiotherapy treatment.

Group Type ACTIVE_COMPARATOR

Exercise Group (CG-1)

Intervention Type BEHAVIORAL

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

Exercise plus monitoring group (TG-2)

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

Group Type EXPERIMENTAL

Exercise plus Monitoring Group (TG-2)

Intervention Type 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)

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.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Exercise Group (CG-1)

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Exercise plus Monitoring Group Exercise Group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No