| Title {1} | 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. |
| Trial registration {2a and 2b}. | German Clinical Trials Register (DRKS00017275). |
| Protocol version {3} | Protocol version 2.0 dated 17 December 2019. |
| Funding {4} | Clinical study sponsor: KAIA Health Software GmbH, Germany |
| Author details {5a} |
Author details Spielmanns, Marc1,2,8; Boeselt, Tobias3; Huber, Stephan4; Kaur Bollinger, Pawandeep4; Ulm, Bernhard7; Pekacka-Egli, Anna Maria1; Jarosch, Inga5; Schneeberger, Tessa5; Schoendorf, Sabine1; Gloeckl Rainer5,6; Koczulla, A Rembert3,5 1,8Pneumologie, Zürcher RehaZentren Klinik Wald, Faltigbergstrasse 7, 8636 Wald, Switzerland 2 Faculty of Health, Department Pulmonary Medicine, University of Witten/Herdecke, Germany 3 Department of Pulmonary Rehabilitation, Philipps-University of Marburg, German Center for Lung Research (DZL), Marburg, Germany 4Fa. KAIA Health GmbH, Siegfriedstr.8, 80,797 München, Germany 5 Institute for Pulmonary Rehabilitation Research, Schoen Klinik Berchtesgadener Land, Schoenau am Koenigssee, Germany 6 Department of Prevention, Rehabilitation and Sports Medicine, Technical University of Munich (TUM), Munich, Germany 7Unabhängiges statistische Beratung Berhard Ulm, Kochelseestr 11, D-81371 München 8corresponding author |
| Name and contact information for the trial sponsor {5b} |
Dr. med. Stephan Huber, Chief Medical officer, Fa. KAIA Health GmbH, Siegfriedstr.8, 80803 München, Germany, Phone: +49 176 22355956, Email: stephan.huber@KAIAhealth.com Dr. Pawandeep Kaur Bollinger, Clinical Project Manager, Fa. KAIA Health GmbH, Siegfriedstr.8, 80803 München, Germany, Phone :+498920207057, Email : pawan.kaurbollinger@KAIAhealth.com |
| Role of sponsor {5c} | Study design, protocol writing, clinical data management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication as per conditions laid out in the Sponsor-Investigator agreement |
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