Abstract
BackgroundThe extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. Early detection of deterioration in lung function and optimising adherence are therefore crucial in CF care. We implement a randomized controlled trial to evaluate efficacy of telemonitoring of adherence, lung function, and health condition in combination with behavior change interventions using innovative digital technologies.MethodsThis is a multi-centre, randomized, controlled, non-blinded trial aiming to include 402 patients ≥ 12 years-of-age with CF. A standard-of-care arm is compared to an arm receiving objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic devices with data transmission to patients and caring physicians combined with video-conferencing, a self-management app and professional telephone coaching. The duration of the intervention phase is 18 months. The primary endpoint is time to the first protocol-defined pulmonary exacerbation. Secondary outcome measures include number of and time between pulmonary exacerbations, adherence to inhalation therapy, changes in forced expiratory volume in 1 s from baseline, number of hospital admissions, and changes in health-related quality of life. CF-associated medical treatment and care, and health care related costs will be assessed by explorative analysis in both arms.DiscussionThis study offers the opportunity to evaluate the effect of adherence interventions using telemedicine capable devices on adherence and lung health, possibly paving the way for implementation of telemedicine in routine care for patients with CF.Trial registration: This study has been registered with the German Clinical Trials Register (Identifier: DRKS00024642, date of registration 01 Mar 2021, URL: https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024642).
Highlights
The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure
The recent development of highly effective Cystic fibrosis transmembrane conductance regulator (CFTR)-directed therapeutics is currently transforming the care of patients with CF leading to an increase in lung function, an improvement in quality of life and a decrease in pulmonary exacerbations [3,4,5]
This development has led to the publication of the first global strategy for digital health by the World Health Organization (WHO) [31]
Summary
The extend of lung disease remains the most important prognostic factor for survival in patients with cystic fibrosis (CF), and lack of adherence is the main reason for treatment failure. The recent development of highly effective CFTR-directed therapeutics is currently transforming the care of patients with CF leading to an increase in lung function, an improvement in quality of life and a decrease in pulmonary exacerbations [3,4,5]. Available information on adherence and lung function would allow for greater patient self-management of the disease and for early intervention and adjustment of therapies by the CF physician, potentially preventing pulmonary exacerbations and slowing lung disease progression
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