Impact of a smartphone application (KAIA COPD app) in combination with Activity Monitoring as a maintenance prOgram following PUlmonary Rehabilitation in COPD: the protocol for the AMOPUR Study, an international, multicenter, parallel group, randomized, controlled study

• DOI: 10.1186/s13063-020-04538-1
• Publication Date: 2020-07-11T04:52:57Z
• Authors: Marc Spielmanns; Tobias Boeselt; Stephan Huber; Pawandeep Kaur Bo...; Bernhard Ulm; Anna-Maria Peckak...; Inga Jarosch; Tessa Schneeberger; Sabine Schoendorf; Rainer Gloeckl; A. Rembert Koczulla
• Keywords: Medicine (General); Maintenance; KAIA COPD; Fitness Trackers; Study Protocol; Pulmonary Disease, Chronic Obstructive; 03 medical and health sciences; R5-920; 0302 clinical medicine; Germany; COPD; Humans; Multicenter Studies as Topic; Exercise; Randomized Controlled Trials as Topic; Physical activity; 16. Peace & justice; Mobile Applications; 3. Good health; Self Care; Smartphone application; Quality of Life; Smartphone; Digital therapeutics; Switzerland

Abstract Background Increasing physical activity (PA) is considered to be an important factor for the efficient management of chronic obstructive pulmonary disease (COPD). Successful methods required achieve improvements in PA following rehabilitation (PR), however, are rarely reported. Therefore, we will conduct this trial evaluate effectiveness using a COPD program delivered patient via KAIA app, mobile medical application, after completion PR. Methods This protocol randomized, controlled, open-label, multicentered that carried out at inpatient PR hospital centers Germany and Switzerland. The interventions involve use app (Arm 1) or active comparator, i.e., usual care 2). Patients completing in-hospital consenting participate study screened with inclusion exclusion criteria enrolled study. After fulfilling screening requirements, patients randomized into one two arms parallel group assignment 1:1 ratio. training participants grouped Arm 1 2 regular recommendations standard by PI. In total, 104 included trial. treatment period last 24 weeks. Electronic versions questionnaires used collect patient-reported assessments remotely. primary outcome measure change intervention comparison control group, measured over week as mean steps per day Polar A 370 tracker, from baseline (end PR) 6-month follow-up. secondary measures functional exercise capacity, health status, sleep quality, exacerbation rate, depression anxiety symptoms assessed several intervals. Discussion seeks prove effects application offers educational, plus monitoring motivational programs can easily implemented patient’s home setting, enabling maintain typically elicited short term long term. Trial registration German Clinical Trials Register ( DRKS00017275 ). Protocol version 2.0 dated 3 June 2019.