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

• Published in: BMC pulmonary medicine Vol. 21; no. 1; p. 131
• Main Authors: Thee, Stephanie, Stahl, Mirjam, Fischer, Rainald, Sutharsan, Sivagurunathan, Ballmann, Manfred, Müller, Axel, Lorenz, Daniel, Urbanski-Rini, Dominika, Püschner, Franziska, Amelung, Volker Eric, Fuchs, Carola, Mall, Marcus Alexander
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 21.04.2021; BioMed Central; BMC
• Subjects: Adherence; Antibiotics; Care and treatment; Clinical trials; Cystic fibrosis; Electronic equipment; Health counseling; Home spirometry; Informed consent; Inhalation; Intervention; Lung diseases; Medical treatment; Methods; Patients; Physicians; Pulmonology; Quality of life; Respiratory function; Respiratory therapy; Spirometry; Study Protocol; Telemedicine; Germany; North America; Adherence; Cystic fibrosis; Home spirometry; Telemedicine
• ISSN: 1471-2466; 1471-2466
• DOI: 10.1186/s12890-021-01500-y

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. 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. This 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. This 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. 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 ).