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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Clinical exacerbation [Срок оценки: At baseline (T1), at 6 months (T2) and at 12 months(T3).]

Вторичные конечные точки (5)

• Dyspnea [Срок оценки: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
• Spirometric function [Срок оценки: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
• Oxigenation [Срок оценки: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
• Functional capacity [Срок оценки: At baseline (T1), at 6 months (T2) and at 12 months(T3).]
• Quality of life (QoL) [Срок оценки: At baseline (T1) and at 12 months(T3).]

Критерии участия

Критерии включения

• Diagnosed cystic fibrosis
• Family access to an internet-enabled device
• Camera and microphone
• Absence of exacerbations in the last 30 days

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Instalaciones de la Universitat de Valencia — Valencia

Идентификаторы

NCT: NCT06313827 · UV-INV_3165929

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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