E84.0
Conditions
Interventions
Group 1: Telemonitoring and Coaching
Patients with CF in the intervention arm receive objective, continuous monitoring of adherence to inhalation therapies, weekly home spirometry using electronic de
Sponsors
Charité Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| time to first protocol-defined pulmonary exacerbation after initiation of the intervention phase | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Germany
Contacts
Public ContactStephanie Thee
Klinik für Pädiatrie m.S. Pneumologie, Immunologie mit Intensivmedizin, Charité – Universitätsmedizin Berlin
Outcome results
None listed