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An mHealth management platform for patients with chronic obstructive pulmonary disease (efil breath): randomized controlled trial
Kwon H, Lee S, Jung EJ, Kim S, Lee J-K, Kim DK, Kim T-H, Lee SH, Lee MK, Song S, Shin K
JMIR MHealth and UHealth 2018 Aug;6(8):e10502
clinical trial
3/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: No. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is one of the major morbidities in public health, and the use of mHealth technology for rehabilitation of patients with COPD can help increase physical activity and ameliorate respiratory symptoms. OBJECTIVE: This study aimed to develop a comprehensive rehabilitation management platform to improve physical activity and quality of life in patients with COPD. METHODS: The study comprised the following 2 stages: (1) a pilot stage in which a prototype app was developed; and (2) a fully-fledged platform development stage in which 2 apps and 1 COPD patient monitoring website were developed. We conducted a randomized clinical trial to investigate the efficacy of the apps developed in the second stage of the study. In addition, two 12-week exercise regimens (fixed and fixed-interactive) were tested for the trial. The clinical parameters of the respiratory function and patient global assessment (PGA) of the app were obtained and analyzed. Notably, Android was the chosen operating system for apps. RESULTS: We developed 2 COPD rehabilitation apps and 1 patient monitoring website. For the clinical trial, 85 patients were randomized into the following 3 groups: 57 were allocated to the 2 intervention groups and 28 to the control group. After 6 weeks, the COPD assessment test scores were significantly reduced in the fixed group (p = 0.01), and signs of improvement were witnessed in the fixed-interactive group. In addition, the PGA score was moderate or high in all aspects of the user experience of the apps in both intervention groups. CONCLUSIONS: A well-designed mobile rehabilitation app for monitoring and managing patients with COPD can supplement or replace traditional center-based rehabilitation programs and achieve improved patient health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT03432117; https://ClinicalTrials.gov/ct2/show/NCT03432117.

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