Fig. 2
Study phases and procedures. During the preparation phase, participants are 1:1 randomized (R) to the intervention group (IG) and control group (CG), study procedures are explained and the correct handling of the study devices is being trained. The IG obtains a telemedicine capable nebulizer (eFlow rapid + nebulizer system, PARI Pharma GmbH, Germany), a home spirometry (mySpiroSense, PARI GmbH, Germany) and a CF therapy management app (PARI Connect App, PARI Pharma GmbH, Germany). The CG also receives a telemedicine capable nebulizer (eTrack Controller with eFlow rapid nebulizer, PARI Pharma Ltd, Germany, and 2net Hub, Philips, North America). During the phase of assessment of adherence, adherence to inhalation therapy is calculated. Adherence data will be available to the patient, caring CF physicians and coach in the IG, but not in the CG. At the end of the assessment phase, the IG is further stratified according to baseline adherence (adherence < 50% group and adherence ≥ 50% group). During the intervention phase, continuous digital monitoring of adherence to inhalation therapies and of lung function is performed in the IG. Participants of the IG can make use of video-conferencing with their caring CF physician up to three times per quarter. Participants of the IG with an adherence < 50% during the assessment phase additionally receive telephone coaching. In the case where mean adherence drops below 50% for at least four weeks in the first six months of the intervention phase in patients with initially good adherence (≥ 50%), these participants will receive a crisis talk followed by telephone coaching. In the last six months of the intervention phase, only monitoring and optional video-conferencing take place.
= quarterly visit outpatient clinic,
= intensive telephone coaching,
telephone coaching,
crisis phone call, t0 = inclusion into study, t1 = start assessment of adherence, t2 = start study intervention, t3 = six months of study intervention, t4 = 12 months of study intervention, t5 = end of study intervention