CFHealthHub 2017.

Study characteristics
Methods	RCT open‐label parallel design Multicentre trial carried out in 19 UK centres Participants were allocated 1:1 to the intervention or usual care using a computer‐generated pseudo‐random list with random‐permuted blocks of randomly varying sizes, via a central, web‐based randomisation system. The allocation sequence was hosted by the Sheffield Clinical Trials Research Unit, with the sequence created by a statistician (not otherwise involved with the trial) and held on a secure server. After recruiting each participant, the trialist logged into the server and entered basic demographic information, then the allocation was revealed to the participants. The paper states that "the trial statistician remained blind to treatment allocation until database freeze", which we understand means that the trial statistician was blinded to treatment allocation until after all data had been collected and entered into the database. Duration: 12 months
Participants	608 participants from 19 centres. Diagnosed with CF and within UK CF Registry. Aged 16 years and over. Participants had to be willing to take all inhaled mucoactive agents and antibiotics via eFlow Technology nebulisers with eTrack data‐logging Controllers (PARI Pharma GmbH, Starnberg, Germany). Age‐ mean age (SD)  CFHealthHub (CFHH) – 31.1 (10.6) N = 304  Usual care – 30.3 (10.8) N = 303 Gender ‐ n (%) female, N CFHH – 156 (51.3) N = 304  Usual care – 154 (50.8) N = 303 Adherence:objectively measured effective adherence (weekly) mean % (SD), N CFHH: 54.1 (33.0) N = 293 Usual care: 45.5 (34.1) N = 295 CFQ‐Rmean score (SD), N Physical domain – CFHH: 54.3 (30.6) N = 304 Usual care: 53.0 (30.2) N = 302 Emotional domain – CFHH: 66.5 (21.6) N = 304 Usual care: 66.2 (24.1) N = 302 FEV1 % predicted, mean (SD), N CFHH: 60.7 (23.5) N = 304 Usual care: 58.3 (22.6) N = 302 Baseline differences described suggest that the intervention group had slightly better lung health (FEV1), were slightly older, had slightly fewer days of IVs over the past year and slightly higher objectively measured adherence.  Exclusion criteria: on active lung transplant list; post lung transplant; receiving palliative care; using inhaled dry powder devices.
Interventions	All participants were given eTrack data‐logging controllers for their eFlow Technology nebulisers which sent time‐stamped and date‐stamped data to a 2net Hub for recording of adherence and inhalation calculation. Intervention Intervention participants had access to the CFHealthHub digital platform (website and smartphone application) and received tailored, flexible support from the interventionist throughout the 12‐month trial period. Control (usual care) Usual care participants used the eTrack data‐logging controllers for adherence data collection. There was no access to CFHealthHub, behavioural change tools or content. Adherence results were invisible to participants and care teams.
Outcomes	Objectively measured effective adherence (%) Treatment burden (CFQ‐R treatment burden domain) Quality of life (CFQ‐R physical, emotional, social, eating, body image, treatment burden, respiratory, digestion domains) Adverse effects (including anxiety and depression score)   FEV1 % predicted Pulmonary exacerbation (exacerbation rate and number of exacerbations and person years)
Notes	The RCT was one part of a larger cohort study which measured adherence to inhaled medication and provided data for further work on improving adherence and behaviour change. Funding source: NIHR Grants for Applied Research programme (RP‐PG‐1212‐20015) and NHS England Commissioning for Quality and Innovation (IM2 Cystic Fibrosis Patient Adherence).