Digital spacer data driven COPD inhaler adherence education: the OUTERSPACE proof-of-concept study

Clinical Research Results Abstract BackgroundInhalers and spacers devices only work when properly used and this remains an ongoing challenge for patients and clinicians. To improve adherence and inhaler technique, a novel digital spacer has been developed. The “smart spacer” is a rechargeable device that measures the exact moment of intake of both reliever and controller and for each actuation it records potential errors like multiple actuations, no inhalation within 30 seconds after actuation, delayed inhalation, excessive flow and low inhaled volume. In this proof-of-concept study that informs the OUtcomes following Tailored Education and Retraining: Studying Performance and AdherenCE (OUTERSPACE) trial program, we aimed to study the effectiveness of this digital “smart spacer”.MethodsIn this single-center study of two months, 12 patients >40 years with spirometry-confirmed COPD (FEV1/FVC<0.7), already using pMDIs with the traditional Aerochamber and no exacerbations in the last 3 months, were included. All patients used the smart spacer during a run-in period of one month. After one month, data were extracted by the pulmonary nurse, inhaler usage patterns were discussed with the patient, and tailored inhaler education and training was provided. Thereafter, patients were provided with a new smart spacer and used it for another month. Outcomes included technique errors, adherence (digitally measured and by Test of Adherence to Inhalers [TAI], lung function, CCQ and System Usability Scale (SUS).ResultsAll 12 patients completed the study. Seven patients used beclomethasone/formoterol/glycopyrronium (Trimbow ® pMDI) and five used beclomethasone/formoterol (Foster ® pMDI) as twice-daily controller medication. Six patients (50%) used Ventolin/salbutamol pMDI as pro re nata reliever in addition. One month after the intervention visit, the mean total number of inhaler errors before and after intervention decreased by 37% (paired t-test, p=0.046). This reduction was mostly driven by a decrease in patients that demonstrated an excessively high flow. Accordingly, the total technique score significantly increased from 65% to 78% (paired t-test, p=0.017). Timely use of the spacer (adherence), was similar in the month before intervention (74,3%) to that in the month thereafter (73,8%). No significant changes in lung function, CCQ or TAI were observed. Patients valued the novel smart spacer with a mean System Usability Score of 79.8 (SD: 12.6).ConclusionThis study highlights the value of digital data driven inhaler education and will inform future studies of the OUTERSPACE program (including studies in adult and pediatric asthma) using the digital spacer. Research Idea Abstract Service Development & Evaluation Abstract Declaration of Interest Funding: TrudellUMCG METc 2020/521; Netherlands Trial Registry ID: NL9037) References and Clinical Trial Registry Information