NCT04299165

Smartphone-App as Maintenance Program in COPD

Impact of a Smartphone Application (KAIA COPD-App) in Combination With Activity Monitoring as Maintenance Program Following Pulmonary Rehabilitation in COPD: an International Multi-centered Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Kaia Health Software · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

Increasing Physical activity (PA) is considered to be an important factor in an efficient management of the chronic obstructive pulmonary disease (COPD). The successful methods required to achieve improvements in PA following Pulmonary Rehabilitation (PR), however are sparsely reported. Therefore, the investigators conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient through a mobile medical application Kaia COPD-App, after the completion of a PR.

Detailed description

This is a randomized, controlled, open-label, multi-centered trial carried out at in-patient PR-hospital centers in Germany and Switzerland . The interventions will involve use of KAIA COPD-app program (Arm 1) or an active comparator i.e. usual care (Arm 2). Patients completing an in-hospital PR-Program and consenting to participate in the study will be screened for the inclusion and exclusion criteria and enrolled in the study. After fulfillment of the screening requirements, they will be randomized into one of the two arms with parallel group assignment in a 1:1 ratio. The training program will be delivered to the participants grouped to the arm 1 through KAIA COPD-App and arm 2 as provided in regular recommendations or standard of care through the PI. In total, 104 participants will be included to the trial. Treatment period will last for 24 weeks. Electronic versions of Questionnaires will be used to collect patient reported assessments remotely. The primary outcome measure is the change in physical activity of the intervention group in comparison to the control group, measured over one week as mean steps per day with the Polar A 370 activity tracker, from baseline (end of PR) to 6-months follow-up. The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, depression and anxiety symptoms assessed at several intervals. This study seeks to prove the implications of the Kaia COPD mobile application in COPD patients after PR. The app offers educational, exercise training plus activity monitoring and motivational program that can be easily implemented in the patient's home-setting enabling patients.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DEVICE	Kaia COPD Application	The study intervention consists of training sessions conducted daily by the patient via the COPD-App.
OTHER	Usual Care	The control group will also be an active control as participants receive a leaflet to convey an active lifestyle and a list of exercises to do at home.

Timeline

• Start date: 2019-08-09
• Primary completion: 2021-06-02
• Completion: 2021-07-03
• First posted: 2020-03-06
• Last updated: 2021-07-28

Locations

2 sites across 2 countries: Germany, Switzerland