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

University of Valencia

Status: Enrolling

Conditions: Cystic Fibrosis

Treatments: Behavioral: Exercise plus monitoring and follow-up group (TGF-3); Behavioral: Exercise plus Monitoring Group (TG-2); Behavioral: Exercise Group (CG-1)

Study type: Interventional

Funder types: Other

Identifiers

NCT06313827

UV-INV_3165929

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Control exercise group (CG-1)

Active Comparator group

Description:

Participants will receive their usual physiotherapy treatment.

Treatment:

Behavioral: Exercise Group (CG-1)

Exercise plus monitoring group (TG-2)

Experimental group

Description:

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

Treatment:

Behavioral: Exercise plus Monitoring Group (TG-2)

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

Experimental group

Description:

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.

Treatment:

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