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

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Autor:innen
Spielmanns, Marc
Boeselt, Tobias
Huber, Stephan
Kaur Bollinger, Pawandeep
Ulm, Bernhard
Jarosch, Inga
Schneeberger, Tessa
Schoendorf, Sabine
Gloeckl, Rainer
Autor:in (Körperschaft)
Publikationsdatum
2020
Typ der Arbeit
Studiengang
Typ
01A - Beitrag in wissenschaftlicher Zeitschrift
Herausgeber:innen
Herausgeber:in (Körperschaft)
Betreuer:in
Übergeordnetes Werk
Trials
Themenheft
Link
Reihe / Serie
Reihennummer
Jahrgang / Band
21
Ausgabe / Nummer
Seiten / Dauer
636
Patentnummer
Verlag / Herausgebende Institution
BioMed Central
Verlagsort / Veranstaltungsort
Auflage
Version
Programmiersprache
Abtretungsempfänger:in
Praxispartner:in/Auftraggeber:in
Zusammenfassung
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 to achieve improvements in PA following pulmonary rehabilitation (PR), however, are rarely reported. Therefore, we will conduct this trial to evaluate the effectiveness of using a COPD management program delivered to the patient via the KAIA COPD app, a mobile medical application, after the completion of PR. Methods This is the protocol for a randomized, controlled, open-label, multicentered trial that will be carried out at inpatient PR hospital centers in Germany and Switzerland. The interventions will involve the use of the 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 with the inclusion and exclusion criteria and enrolled in the study. After fulfilling the screening requirements, the patients 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 in Arm 1 via the KAIA COPD app and to participants grouped in Arm 2 via the regular recommendations or standard of care by the PI. In total, 104 participants will be included in the trial. The 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 1 week as the mean steps per day with a Polar A 370 activity tracker, from baseline (end of PR) to the 6-month follow-up. The secondary outcome measures are functional exercise capacity, health status, sleep quality, exacerbation rate, and depression and anxiety symptoms assessed at several intervals. Discussion This study seeks to prove the effects of the KAIA COPD mobile application in COPD patients after PR. The app offers educational, exercise training plus activity monitoring and motivational programs that can be easily implemented in the patient’s home setting, enabling patients to maintain the effects that are typically elicited in the short term after pulmonary rehabilitation for the long term. Trial registration German Clinical Trials Register (DRKS00017275). Protocol version 2.0 dated 3 June 2019.
Schlagwörter
Fachgebiet (DDC)
610 - Medizin und Gesundheit
Projekt
Veranstaltung
Startdatum der Ausstellung
Enddatum der Ausstellung
Startdatum der Konferenz
Enddatum der Konferenz
Datum der letzten Prüfung
ISBN
ISSN
1745-6215
1468-6708
1468-6694
Sprache
Englisch
Während FHNW Zugehörigkeit erstellt
Nein
Publikationsstatus
Veröffentlicht
Begutachtung
Peer-Review der ganzen Publikation
Open Access-Status
Gold
Lizenz
'https://creativecommons.org/licenses/by/4.0/'
Zitation
SPIELMANNS, Marc, Tobias BOESELT, Stephan HUBER, Pawandeep KAUR BOLLINGER, Bernhard ULM, Anna Maria PEKACKA-EGLI, Inga JAROSCH, Tessa SCHNEEBERGER, Sabine SCHOENDORF, Rainer GLOECKL und A. Rembert KOCZULLA, 2020. 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. Trials. 2020. Bd. 21, S. 636. DOI 10.1186/s13063-020-04538-1. Verfügbar unter: https://doi.org/10.26041/fhnw-10026