Category: Parkinson’s Disease: Clinical Trials
Objective: Here we present the development of a novel platform to deliver the Roche Parkinson’s Disease (PD) Mobile Application to researchers to actively measure motor symptom severity and progression in Parkinson’s disease (PD) using a downloadable smartphone application.
Background: Digital health technology tools (DHTTs) enable remote and frequent monitoring of motor symptoms in Parkinson’s disease (PD). Previous investigations with the Roche PD Mobile Application running on study smartphones provided to participants demonstrated strong patient adherence, high test-retest reliability of sensor features, significant correlations with clinical data (MDS-UPDRS), high sensitivity to clinically undetected manifestations of PD symptoms and the ability to detect changes over time [1,2]. However, patient user feedback recommended a Bring-Your-Own-Device (BYOD) option, in which research participants download the application onto their private smartphones [3]. A BYOD solution may reduce participant burden, while at the same time facilitating the dissemination of this technology.
Method: The novel Roche BYOD DHTT platform is currently under development based on learnings from earlier deployments of the Roche PD Mobile Application in a phase 1 (NCT02095171), phase 2 PASADENA (NCT03100149), phase 2 PADOVA (NCT04777331) and PPMI [4] studies. It will provide partnered users a downloadable smartphone application, a web-based platform to register participants and activate the app, data delivery and support. The downloadable application will comprise 12 active tasks (including tremor, bradykinesia, rigidity/postural stability, cognition) and selected patient-reported outcomes, and will be available for both Android and iOS operating systems.
Results: Details of the active tasks, patient reported outcomes, schedules of assessment, platform configuration, sensor feature delivery and data sharing setup will be presented.
Conclusion: The new Roche DHTT platform will enable researchers to remotely collect data on the core signs of PD remotely, continuously (i.e., daily) and objectively (i.e., via smartphone sensors). The availability of this platform to partnered studies would facilitate data comparability across studies and support the community to better understand PD and its progression.
References: [1] Lipsmeier, F., Taylor, K.I., Kilchenmann, T., Wolf, D., Scotland, A., Schjodt‐Eriksen, J., Cheng, W.Y., Fernandez‐Garcia, I., Siebourg‐Polster, J., Jin, L. and Soto, J., 2018. Evaluation of smartphone‐based testing to generate exploratory outcome measures in a phase 1 Parkinson’s disease clinical trial. Movement Disorders, 33(8), pp.1287-1297.
[2] Lipsmeier, F., Taylor, K.I., Postuma, R.B., Volkova-Volkmar, E., Kilchenmann, T., Mollenhauer, B., Bamdadian, A., Popp, W.L., Cheng, W.Y., Zhang, Y.P. and Wolf, D., 2021. Remote monitoring of progression in early Parkinson’s disease: reliability and validity of the Roche PD Mobile Application v2. medRxiv.
[3] Fehlmann, B., Thomann, A., Popp, W., Lipsmeier, F., Volkova-Volkmar, E., Friess, J., Svoboda, H., Pagano, G., Kilchenmann, T., Bamdadian, A. and Zago, W., 2021, September. Relationship of satisfaction and adherence in remote digital monitoring: Results from a clinical drug trial in early Parkinson’s disease. In MOVEMENT DISORDERS (Vol. 36, pp. S171-S171). 111 RIVER ST, HOBOKEN 07030-5774, NJ USA: WILEY.
[4] Marek, K., Siderowf, A., Simuni, T., Chahine, L., Kieburtz, K., Mollenhauer, B., Galasko, D., Merchant, K., Brown, E., Coffey, C. and Dobkin, R., 2021, September. Parkinson Progression Marker Initiative-New Science/New Cohorts. In MOVEMENT DISORDERS (Vol. 36, pp. S187-S187). 111 RIVER ST, HOBOKEN 07030-5774, NJ USA: WILEY.
To cite this abstract in AMA style:
W. Popp, K. Taylor, A. Bamdadian, L. Restelli, J. Schjodt-Eriksen, G. Pagano, H. Svoboda, A. Bonni, M. Lindemann. Scaling the Roche Digital Health Technology Platform to Assess Disease Severity and Progression in Individuals with Parkinson’s Disease [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/scaling-the-roche-digital-health-technology-platform-to-assess-disease-severity-and-progression-in-individuals-with-parkinsons-disease/. Accessed November 21, 2024.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/scaling-the-roche-digital-health-technology-platform-to-assess-disease-severity-and-progression-in-individuals-with-parkinsons-disease/