1. Medical App Treatment of Non-Specific Low Back Pain in the 12-month Cluster-Randomized Controlled Trial Rise-uP: Where Clinical Superiority Meets Cost Savings
- Author
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Priebe JA, Kerkemeyer L, Haas KK, Achtert K, Moreno Sanchez LF, Stockert P, Spannagl M, Wendlinger J, Thoma R, Jedamzik SU, Reichmann J, Franke S, Sundmacher L, Amelung VE, and Toelle TR
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digital medicine ,medical apps ,non-specific low back pain ,multimodal pain therapy ,healthcare costs ,behavioral tracking analysis ,Medicine (General) ,R5-920 - Abstract
Janosch A Priebe,1 Linda Kerkemeyer,2 Katharina K Haas,1 Katharina Achtert,2 Leida F Moreno Sanchez,1,3 Paul Stockert,1 Maximilian Spannagl,1 Julia Wendlinger,1 Reinhard Thoma,4 Siegfried Ulrich Jedamzik,3 Jan Reichmann,5 Sebastian Franke,6 Leonie Sundmacher,6 Volker E Amelung,2 Thomas R Toelle1 1Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum Rechts der Isar, Technical University of Munich (TUM), Munich, Germany; 2Institute for Applied Health Services Research, Inav GmbH, Berlin, Germany; 3Bayerische TelemedAllianz, Ingolstadt, Baar-Ebenhausen, Germany; 4Pain Clinic, Algesiologikum Pain Center, Munich, Germany; 5StatConsult GmbH Magdeburg, Magdeburg, Germany; 6Department of Health Economics, Faculty of Sports and Health Sciences, Technical University of Munich (TUM), Munich, GermanyCorrespondence: Thomas R Toelle, Center of Interdisciplinary Pain Medicine, Department of Neurology, Klinikum rechts der Isar, Technical University of Munich (TUM), Ismaninger Str. 22, Munich, 81675, Germany, Tel +49-89-4140-4613, Email thomas.toelle@tum.dePurpose: Non-specific low back pain (NLBP) exerts a profound impact on global health and economics. In the era of Web 3.0, digital therapeutics offer the potential to improve NLBP management. The Rise-uP trial introduces a digitally anchored, general practitioner (GP)-focused back pain management approach with the Kaia back pain app as the key intervention. Here, we present the 12-months evaluation of the Rise-uP trial including clinical and economic outcomes, patient satisfaction and behavioral tracking analysis.Methods: The cluster-randomized controlled study (registration number: DRKS00015048) enrolled 1237 patients, with 930 receiving treatment according to the Rise-uP approach and 307 subjected to standard of care treatment. Assessments of pain, psychological state, functional capacity, and well-being (patient-reported outcome measures; PROMs) were collected at baseline, and at 3-, 6-, and 12-months follow-up intervals. Health insurance partners AOK, DAK, and BARMER provided individual healthcare cost data. An artificial intelligence (AI)-driven behavioral tracking analysis identified distinct app usage clusters that presented all with about the same clinical outcome. Patient satisfaction (patient-reported experience measures; PREMs) was captured at the end of the trial.Results: Intention-to-treat (ITT) analysis demonstrated that the Rise-uP group experienced significantly greater pain reduction at 12 months compared to the control group (IG: − 46% vs CG: − 24%; p < 0.001) with only the Rise-uP group achieving a pain reduction that was clinically meaningful. Improvements in all other PROMs were notably superior in patients of the Rise-uP group. The AI analysis of app usage discerned four usage clusters. Short- to long-term usage, all produced about the same level of pain reduction. Cost-effectiveness analysis indicated a substantial economic benefit for Rise-uP.Conclusion: The Rise-uP approach with a medical multimodal back pain app as the central element of digital treatment demonstrates both, clinical and economic superiority compared to standard of care in the management of NLBP.Keywords: digital medicine, medical apps, non-specific low back pain, multimodal pain therapy, healthcare costs, behavioral tracking analysis
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- 2024