Cystic Fibrosis
Conditions
Keywords
e-Health, physiotherapy, Cystic fibrosis, exacerbation, quality of life
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.
Interventions
BEHAVIORALExercise 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.
BEHAVIORALExercise 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.
BEHAVIORALExercise Group (CG-1)
Participants who will receive their usual physiotherapy treatment and user education on bronchial care and hygiene
Sponsors
Asociación de Fibrosis Quística - Comunidad Valenciana
University of Valencia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical exacerbation | At baseline (T1), at 6 months (T2) and at 12 months(T3). | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | At baseline (T1), at 6 months (T2) and at 12 months(T3). | Modified Medical Research Council (mMRC) scale (0 to 4 points). Higher scores are related to higher dyspnea. |
| Spirometric function | At baseline (T1), at 6 months (T2) and at 12 months(T3). | Forced expiratory volume in the first second (FEV1) in L/sec |
| Functional capacity | At baseline (T1), at 6 months (T2) and at 12 months(T3). | 30 seconds sit-to-stand test (in number of repetitions) |
| Quality of life (QoL) | At baseline (T1) and at 12 months(T3). | Cystic fibrosis questionnaire-revised (in score points). It is a 0-100 scale with higher scores indicating better quality of life. |
| Oxigenation | At baseline (T1), at 6 months (T2) and at 12 months(T3). | Oxyhemoglobin saturation in percent. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Motivation to engage in physical activity | At baseline (T1) | 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. |
Countries
Spain
Contacts
Primary ContactFrancisco Martinez-Arnau, PhD
Outcome results
None listed