Contact (EU and non-US countries)

Responsible

VAT ID: DE305934424
Court: Munich, Amtsgericht München HRB 224467
Managing Director: Graham Lewis
Responsible person according to German law § 55 Abs. 2 RStV: Graham Lewis

For media enquiries and interviews

Kaia COPD is a medical device of class IIa.

Intended use

Kaia COPD is a medical product for use by people with COPD based on the concept of pulmonary rehabilitation. Kaia delivers new course units daily to promote physical activity and to help proactively manage COPD. Kaia COPD supports people above the age of 18 years with a diagnosis of COPD (J44.-) as long as contraindications and other causes for symptoms which require specific therapy are excluded. Kaia COPD cannot diagnose conditions or injuries and cannot be used in lieu of a medical consultation.

Indication

• COPD (J44.-)

Contraindications

• Advanced heart failure (I50.-), heart disease or other unexplained cardiovascular complaints (I51.-)
• Pulmonary Embolism, Pulmonary infarction (I26.-) or deep vein thrombosis (DVT) (I80.2-)
• Current exacerbation or respiratory infection (both with shortness of breath) (J44.1-)
• Pregnancy (O09.-)

Relative Contraindications

• Musculoskeletal conditions such as herniated discs (M51.-) or decreased bone density (M80.- / M81.-), or previous spinal surgery (Z98.-)
• Neurological condition such as a previous cerebrovascular accident (CVA) (stroke) (I63.-)
• Gait imbalance (R26.-), tendency to fall (R29.6-)
• Unexplained chest pain (I51.9) or previous myocardial infarction (I21.-)

Intended use environment

Kaia COPD can be used with or without supervision and should be used once daily, between 3 and 7 times a week unless instructed otherwise by a doctor. We recommend connecting to Wifi to ensure best performance. Some exercises require common household items such as a water bottle, a towel or a chair. An overview of all required items is shown in the app before each physical exercise module.

Sources for the health information provided in the app, as well as sources for the medical content and procedures implemented in the app, such as guidelines, textbooks, and studies

• Bestall JC, Paul EA, Garrod R, Garnham R, Jones PW, Wedzicha JA. Usefulness of the Medical Research Council (MRC) dyspnoea scale as a measure of disability in patients with chronic obstructive pulmonary disease. Thorax 1999; 54(7): 581-6.
• Bourbeau J, Nault D, Dang-Tan T. Self-management and behaviour modification in COPD. Patient Educ Couns. 2004 Mar 1;52(3):271–7.
• Bourne S, DeVos R, North M, et al. Online versus face-to-face pulmonary rehabilitation for patients with chronic obstructive pulmonary disease: randomised controlled trial. BMJ Open 2017; 7(7): e014580
• Bundesärztekammer. Nationale VersorgungsLeitlinie COPD - Konsultationsfassung [Internet]. 2. Auflage, 2020. Available from: https://www.leitlinien.de/mdb/downloads/nvl/copd/copd-2aufl-konsultation.pdf
• Coultas DB, Jackson BE, Russo R, et al. Home-based Physical Activity Coaching, Physical Activity, and Health Care Utilization in Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease Self-Management Activation Research Trial Secondary Outcomes. Ann Am Thorac Soc 2018; 15(4): 470-8
• Fletcher CM. Standardised questionnaire on respiratory symptoms: a statement prepared and approved by the MRC Committee on the Aetiology of Chronic Bronchitis (MRC breathlessness score). BMJ 1960; 2: 1662.53.
• Garvey C, Bayles MP, Hamm LF, et al. Pulmonary Rehabilitation Exercise Prescription in Chronic Obstructive Pulmonary Disease: Review of Selected Guidelines: An official statement from the American Association of Cardiovascular and Pulmonary Rehabilitation J Cardiopulm Rehabil Prev 2016; 36(2): 75-83
• Gloeckl R, Schneeberger T, Jarosch I, Kenn K. Pulmonary rehabilitation and exercise training in chronic obstructive pulmonary disease. Dtsch Arztebl Int. 2018;115(8):117–23.
• Gordon CS, Waller JW, Cook RM, Cavalera SL, Lim WT, Osadnik CR. Effect of Pulmonary Rehabilitation on Symptoms of Anxiety and Depression in COPD: A Systematic Review and Meta-Analysis. Chest 2019; 156(1): 80-91.
• Guell MR, Cejudo P, Ortega F, et al. Benefits of Long-Term Pulmonary Rehabilitation Maintenance Program in Patients with Severe Chronic Obstructive Pulmonary Disease. Three-Year Follow-up. Am J Respir Crit Care Med 2017; 195(5): 622-9
• Holland AE, Mahal A, Hill CJ, et al. Home-based rehabilitation for COPD using minimal resources: a randomised, controlled equivalence trial. Thorax 2017; 72(1): 57-65.266.
• Horowitz MB, Littenberg B, Mahler DA. Dyspnea ratings for prescribing exercise intensity in patients with COPD. Chest 1996; 109(5): 1169-75.
• Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD Assessment Test. Eur Respir J 2009; 34(3): 648-54.
• Karloh M, Fleig Mayer A, Maurici R, Pizzichini MM, Jones PW, Pizzichini E. The COPD Assessment Test: What Do We Know So Far?: A Systematic Review and Meta-Analysis About Clinical Outcomes Prediction and Classification of Patients Into GOLD Stages. Chest 2016; 149(2): 413-25
• Maltais F, Bourbeau J, Shapiro S, et al. Effects of home-based pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a randomized trial. Ann Intern Med 2008; 149(12): 869-78.267.
• McCarthy B, Casey D, Devane D, Murphy K, Murphy E, Lacasse Y. Pulmonary rehabilitation for chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2015; 2(2): CD003793
• Oga T, Nishimura K, Tsukino M, Sato S, Hajiro T. Analysis of the factors related to mortality in chronic obstructive pulmonary disease: role of exercise capacity and health status. Am J Respir Crit Care Med 2003; 167(4): 544-9
• Puhan MA, Gimeno-Santos E, Cates CJ, Troosters T. Pulmonary rehabilitation following exacerbations of chronic obstructive pulmonary disease. Cochrane Database Syst Rev 2016; 12: CD005305
• Soriano JB, Lamprecht B, Ramirez AS, et al. Mortality prediction in chronic obstructive pulmonary disease comparing the GOLD 2007 and 2011 staging systems: a pooled analysis of individual patient data. Lancet Respir Med2015; 3(6): 443-50
• Spruit MA, Singh SJ, Garvey C, et al. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med 2013; 188(8): e13-64.249.
• Vogiatzis I, Rochester CL, Spruit MA, Troosters T, Clini EM, American Thoracic Society/European Respiratory Society Task Force on Policy in Pulmonary Rehabilitation. Increasing implementation and delivery of pulmonary rehabilitation: key messages from the new ATS/ERS policy statement. Eur Respir J 2016; 47(5): 1336-41.
• Waschki B, Kirsten A, Holz O, et al. Physical activity is the strongest predictor of all-cause mortality in patients with COPD: a prospective cohort study. Chest 2011; 140(2): 331-42
• GOLD Report. Global initiative for chronic obstructive lung disease 2020 Report. Glob Initiat Chronic Obstr Lung Dis [Internet]. 2020; Available from: https://goldcopd.org/wp-content/uploads/2019/11/GOLD-2020-REPORT-ver1.0wms.pdf / https://goldcopd.org/gold-reports/
• Content and images adapted from the “Living Well with COPD” program. J. Bourbeau, D. Nault, M. Sedeno, et al., 3rd edition (2020). www.livingwellwithcopd.com

Studies on the app (in progress or completed)

• Spielmanns, M., Boeselt, T., Huber, S., Kaur Bollinger, P., Ulm, B., Peckaka-Egli, A.-M., Jarosch, I., Schneeberger, T., Schoendorf, S., Gloeckl, R., & Koczulla, A. R. (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, 21(1), 636. (Laufende Randomisierte Kontrollierte Studie)
• Rassouli, F., Boutellier, D., Duss, J., Huber, S., & Brutsche, M. H. (2018). Digitalizing multidisciplinary pulmonary rehabilitation in COPD with a smartphone application: An international observational pilot study. International Journal of Chronic Obstructive Pulmonary Disease, 13, 3831–3836. https://doi.org/10.2147/COPD.S182880
• Effekte einer Smartphone-Applikation (Kaia COPD) zur selbstgerichteten pneumologischen Rehabilitation symptomatischer COPD-Patienten im häuslichen Umfeld - eine randomisierte, kontrollierte multizentrische und internationale klinische Studie- COPD02 Koala Study. (Laufende Randomisierte Kontrollierte Studie, Registrierung beim Deutschen Register klinischer Studien (DRKS-ID: DRKS00024390).

The applicable Terms and Conditions and Privacy Policy can be found at www.kaiahealth.de.

The standards and profiles used for the interoperability of our medical device can be viewed on the simplifier.net/kaia website.