Efficacy and Acceptability of a Mobile App for Monitoring the Clinical Status of Patients With Chronic Obstructive Pulmonary Disease Receiving Home Oxygen Therapy: Randomized Controlled Trial.

backgroundChronic obstructive pulmonary disease (COPD) primarily originates from exposure to tobacco smoke, although factors, such as air pollution and exposure to chemicals, also play a role. One of the primary treatments for COPD is oxygen therapy, which helps manage dyspnea and improve survival rates. Mobile health (mHealth) technologies have demonstrated significant potential in monitoring patients with chronic diseases, offering new avenues for enhancing patient care and disease management.

objectiveThe purpose of this study was to evaluate the efficacy and acceptability of a mobile app designed for the clinical monitoring of patients with COPD and home oxygen (HO) therapy, compared with conventional monitoring in real-world community settings.

methodsA parallel-group, nonblinded, multicenter randomized controlled trial was conducted with 45 participants; the intervention group (IG), which used the mobile app in addition to conventional monitoring (n=23) and the control group, which received only conventional monitoring (n=22), administered by therapists over a duration of 3 months. The primary outcomes included the chronic obstructive pulmonary disease assessment test (CAT) score, the level of dyspnea measured by the Borg scale, and oxygen saturation percentage, assessed at both the beginning and end of the trial. Secondary outcomes included the frequency of app use, the number of hospitalizations, and survival rates. In addition, a satisfaction survey and an interview were conducted with the IG.

resultsThe median use of the mobile app was 21 (IQR 16-28) days. At the end of the follow-up, the Borg dyspnea scale was significantly lower in patients who used the mobile app for HO therapy monitoring (mean 0.6, SD 0.8 vs mean 4.1, SD 1.4; P=.001). Regarding the impact of COPD on quality of life, as measured by the CAT, no differences were found in the scores between baseline and end-of-follow-up within the control group. However, a significant decrease was observed in the IG (baseline median CAT 27, IQR 23-31 vs final median CAT 22, IQR 14-28; P<.001). In addition, the CAT score was significantly higher in patients receiving conventional monitoring compared with those monitored with the mobile app (median 30, IQR 23-32 vs median 22, IQR 14-28; P=.02).

conclusionsThe use of the mobile app, AppO2 (SINCO), designed for the clinical monitoring of patients with COPD and HO therapy, is associated with improved quality of life. In addition, the app is highly accepted by users, promotes self-care, and fosters patient confidence in managing their own condition.

trial registrationClinicalTrials NCT04820790; https://clinicaltrials.gov/study/NCT04820790. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-https://doi.org/10.1186/s12875-021-01450-8.