Survey instrument/collected data | t0 | t1 | t2 | t3 | t4 | t5 |
---|---|---|---|---|---|---|
Anthropometric data | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Sociodemographic data | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Clinical history | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Clinical findings | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Lung function test | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Therapy plan | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Pulmonary exacerbations since last study visit | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Time period until first pulmonary exacerbation since beginning of study intervention | IG/CG | IG/CG | IG/CG | |||
Time between pulmonary exacerbations since last study visit | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
CF-associated hospital admissions since last study visit | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Days absent from work or school since last study visit | IG/CG | IG/CG | IG/CG | |||
CF-associated medical treatment and care since last study visit | IG/CG | IG/CG | IG/CG | |||
Telemonitoring (App) | ||||||
Continuous monitoring of adherence to inhalation therapy | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
continuously | ||||||
Weekly lung function measured by home spirometrya | IC | IC | IC | IC | ||
at least 1x/week | ||||||
Patient questionnaire | ||||||
Quality of life: EQ-5D-5L /. EQ-5D-Y-5L | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Quality of life: CFQ-R | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Beck Depression Inventar | IG/CG | IG/CG | IG/CG | IG/CG | IG/CG | |
Expectations and their fulfilment regarding the new form of care | IG/ relatives | IG/ relatives | ||||
Telephone interview | ||||||
acceptance, satisfaction, potential for optimization, barriers and implementation into standard care | IG/physician/ relatives |