A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF

BMC Pulmonary Medicine

Rainald Fischer¹  Stephanie Thee²  Mirjam Stahl³  Marcus Alexander Mall⁴  Manfred Ballmann⁵  Sivagurunathan Sutharsan⁶  Carola Fuchs⁷  Dominika Urbanski-Rini⁸  Volker Eric Amelung⁸  Franziska Püschner⁸  Daniel Lorenz⁹  Axel Müller^1,10 

[1] Cystic Fibrosis Centre Munich-West, Munich, Germany;Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité – Universitätsmedizin Berlin, Berlin, Germany;Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité – Universitätsmedizin Berlin, Berlin, Germany;German Centre for Lung Research (DZL), Associated Partner, Berlin, Germany;Department of Pediatric Respiratory Medicine, Immunology and Critical Care Medicine, Division of Cystic Fibrosis, Charité – Universitätsmedizin Berlin, Berlin, Germany;German Centre for Lung Research (DZL), Associated Partner, Berlin, Germany;Berlin Institute of Health (BIH), Berlin, Germany;Department of Pediatrics, University Medicine Rostock, Rostock, Germany;Department of Pulmonary Medicine, Division of Cystic Fibrosis, University Medicine Essen -Ruhrlandklinik, University of Duisburg-Essen, Essen, Germany;PARI Medical Holding GmbH, Starnberg, Germany;Private Institute for Applied Health Services Research (Inav) GmbH, Berlin, Germany;Thieme TeleCare Ltd., Stuttgart, Germany;m.Doc GmbH, Köln, Germany;

关键词: Cystic fibrosis;    Telemedicine;    Adherence;    Home spirometry;   

DOI  :  10.1186/s12890-021-01500-y

来源: Springer

【 摘 要 】

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).

【 授权许可】

CC BY