Thee 2021.
| Study name | ConneCT CF |
| Methods | Multicentre, randomised, controlled, non‐blinded trial 1:1 randomisation performed by an electronic data capture system |
| Participants | Aiming to recruit 402 participants aged 12 years or over with CF Participants must have had at least one pulmonary exacerbation (Bilton criteria) in the year before enrolment, FEV1 < 90%, and if on CFTR modulator therapy, participants must be stable for the last three months. |
| Interventions | There is a six‐week preparation phase where participants are trained to use the study devices. Intervention group: participants are given a telemedicine‐capable nebuliser (eFlow rapid+ nebuliser system consisting of an eTrack Controller with eFlow rapid nebuliser handset, PARI Pharma GmbH, Germany), home spirometry (mySpiroSense, PARI GmbH, Germany) and a CF therapy management app (PARI Connect App, PARI Pharma GmbH, Germany) to support self‐management, provide adherence monitoring and transfer lung function values. Data on date, duration and inhaled agent will be collected and automatically transferred to a web cloud‐based telemedicine data server. Control group: also receives a telemedicine‐capable nebuliser (eTrack Controller with eFlow rapid nebuliser, PARI Pharma Ltd, Germany, and 2net Hub, Philips, North America). Data on adherence will be automatically tracked for final evaluation without any data access for participants or caring CF physicians in this group. After the preparation phase, there is a four‐week assessment phase where adherence to inhaled therapy will be tracked in both groups to provide a baseline. In the intervention phase (18 months), continuous digital monitoring of adherence and lung function is performed in the intervention group. Adherence is calculated and displayed to the participant and the CF physician. Lung function measurements are performed once a week and a graph is generated which is displayed to the participant and the CF physician. Intervention group participants can also make use of video conferencing with their CF physician up to three times a quarter. The CF physician will also request a videoconferencing session if FEV1 drops by 5% compared to the mean of the two previous values. There will also be psychological support. In the control group, there will also be continuous monitoring of adherence to inhaled therapies but this is not displayed to the participant or the CF physician. |
| Outcomes | Primary outcome is time to first protocol‐defined pulmonary exacerbation after initiation of the intervention phase. Secondary outcomes include: the number of pulmonary exacerbations; time between exacerbations; adherence to inhaled therapy; change in FEV1 and FVC from baseline; hospital admissions; change in health‐related quality of life (Cystic Fibrosis Questionnaire ‐ Revised (CFQ‐R) and EuroQoL 5‐dimension (EQ‐5D‐5L)); sociodemographic and anthropometric data; days absent from work or school and CF‐associated medical treatment and healthcare‐related costs. |
| Starting date | March 2021 |
| Contact information | Marcus Mall
Address: Augustenburger Platz 1 13353 Berlin Germany
Telephone:030 450 566 128
Email:marcus.mall@charite.de Stephanie Thee Address: Augustenburger Platz 1 13353 Berlin Germany Telephone: 030 450 566 128 Email: Stephanie.thee@charite.de |
| Notes |
CF: cystic fibrosis CFTR: cystic fibrosis transmembrane conductance regulator FEV1: forced expiratory volume in 1 second FVC: forced vital capacity RCT: randomised controlled trial