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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Healthy Volunteers: f
View:

• Diagnosed cystic fibrosis

• Family access to an internet-enabled device

• Camera and microphone

• Absence of exacerbations in the last 30 days

Locations
Other Locations
Spain
Instalaciones de la Universitat de Valencia
RECRUITING
Valencia
Contact Information
Primary
Francisco Martinez-Arnau, PhD
francisco.m.martinez@uv.es
0034963983853
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2027-01
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of Valencia
Collaborators: Asociación de Fibrosis Quística - Comunidad Valenciana

This content was sourced from clinicaltrials.gov