dc.contributor.author
Thee, Stephanie
dc.contributor.author
Stahl, Mirjam
dc.contributor.author
Fischer, Rainald
dc.contributor.author
Sutharsan, Sivagurunathan
dc.contributor.author
Ballmann, Manfred
dc.contributor.author
Müller, Axel
dc.contributor.author
Lorenz, Daniel
dc.contributor.author
Urbanski-Rini, Dominika
dc.contributor.author
Püschner, Franziska
dc.contributor.author
Amelung, Volker Eric
dc.contributor.author
Fuchs, Carola
dc.contributor.author
Mall, Marcus Alexander
dc.date.accessioned
2023-03-14T13:09:05Z
dc.date.available
2023-03-14T13:09:05Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/38370
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-38089
dc.description.abstract
Background: 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.
Methods: 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.
Discussion: 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.
en
dc.rights.uri
https://creativecommons.org/licenses/by/4.0/
dc.subject
Cystic fibrosis
en
dc.subject
Telemedicine
en
dc.subject
Home spirometry
en
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit
dc.title
A multi-centre, randomized, controlled trial on coaching and telemonitoring in patients with cystic fibrosis: conneCT CF
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation.articlenumber
131
dcterms.bibliographicCitation.doi
10.1186/s12890-021-01500-y
dcterms.bibliographicCitation.journaltitle
BMC Pulmonary Medicine
dcterms.bibliographicCitation.originalpublishername
Springer Nature
dcterms.bibliographicCitation.volume
21
refubium.affiliation
Charité - Universitätsmedizin Berlin
refubium.funding
Springer Nature DEAL
refubium.resourceType.isindependentpub
no
dcterms.accessRights.openaire
open access
dcterms.bibliographicCitation.pmid
33882893
dcterms.isPartOf.eissn
1471-2466