Coaching and Telemonitoring in Patients with Cystic Fibrosis: ConneCT CF
Not Applicable
- Conditions
- E84.0Cystic fibrosis with pulmonary manifestations
- Registration Number
- DRKS00024642
- Lead Sponsor
- Charité Campus Virchow-Klinikum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 296
Inclusion Criteria
confirmed diagnosis of CF, be age 12 years or older and be able to give informed consent or assent, if receiving a CFTR modulator therapy, stable on this treatment for the last three preceding months with no planned change in CFTR modulator treatment during the study period
Exclusion Criteria
acute depressive or psychotic episode, substantial immobility, no prescribed inhalation therapy, insufficient knowledge of the German language, lack of possession of a smartphone, being post lung-transplantation, not being able to perform lung function testing, or lung function testing being contradicted
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method time to first protocol-defined pulmonary exacerbation after initiation of the intervention phase
- Secondary Outcome Measures
Name Time Method number of pulmonary exacerbations, time between pulmonary exacerbations, adherence to inhalation therapy, changes of FEV1 and forced vital capacity (FVC) from baseline, number of CF-associated hospital admissions, and changes in health-related quality of life (assessed by CFQR German version and EQ-5D-5L/EQ-5D-Y-5L), non-somatic depression symptoms (Beck Depression Inventar- Fast Screen), sociodemographic and anthropometric data, number of days absent from work or school, and CF associated medical treatment and care, health care related costs