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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06313827
• Other study ID #: UV-INV_3165929
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: University of Valencia
• Contact: Francisco Martinez-Arnau, PhD
• Phone: 0034963983853
• Email: francisco.m.martinez[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• 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.
• 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.
• Exercise Group (CG-1)
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene

Locations

Country	Name	City	State
Spain	Universitat de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Asociación de Fibrosis Quística - Comunidad Valenciana

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Motivation to engage in physical activity	A confidential online ad-hoc 13-item survey regarding their views, opinions and practices in relation to physical activity. This is a survey that is analyzed qualitatively.	At baseline (T1)
Primary	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	Dyspnea	Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea.	At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary	Spirometric function	Forced expiratory volume in the first second (FEV1) in L/sec	At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary	Oxigenation	Oxyhemoglobin saturation in percent.	At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary	Functional capacity	30 seconds sit-to-stand test (in number of repetitions)	At baseline (T1), at 6 months (T2) and at 12 months(T3).
Secondary	Quality of life (QoL)	Cystic fibrosis questionnaire-revised (in score points). It is a 0-100 scale with higher scores indicating better quality of life.	At baseline (T1) and at 12 months(T3).