Protocol of the interdisciplinary and intersectoral randomized controlled trial in Parkinson patients in a specialized network in Germany: the INSPIRE Trial
Year: 2026
Type: article
Study design: Study Protocol
Abstract: INSPIRE-PNRM+ (short for InterdiSciPlinary and InteRsectoral telemedIcal Evaluation, Coordination and Therapy at the ParkinsonNet RheinMain+) is an one-year, multicentre, interventional, open-label, two-arm, 1:1 randomized controlled trial (RCT) with the goal to improve the quality of care for Parkinson’s disease (PD) patients outside of a specialized clinical context. The study is funded by the German Innovation Fund mandated by the Federal Joint Committee (G-BA). The three core characteristics are (1) the employment of specially trained advanced practice nurses (APN) in an (2) interdisciplinary network and (3) the use of a specifically designed digital platform. This platform serves for documentation and communication, thereby helping patients receive individualized, guideline-based treatment and support in adapting their lives to the effects of the disease. 844 patients will be recruited. They will be divided into two groups: a “usual care” group which continues traditional care (i.e., usually consultation with a neurologist in private practice) vs. the “intervention” group which will have APN contact every three months or more frequently as needed over the period of 12 months. Patients’ quality of life serves as primary outcome measure, combined with a process evaluation and health economic analysis (cost-utility analysis (CUA)). Recruitment was ongoing at time of submission of this paper. This innovative study is the first in Germany where APNs are dedicated to PD care. The study may serve as blueprint when incorporating APNs into routine healthcare, similar to other countries. TRIAL REGISTRATION: The study has been registered at www.clinicaltrials.gov , NCT06479083. Registered June 27, 2024. https://clinicaltrials.gov/study/NCT06479083?term=INSPIRE%20Parkinson&rank=1 .
Authors: Susanne A. Schneider, Sandra Paryjas, Franziska Beyer, Jan-Philipp Bach, Simon Baudrexel, Bernhard Baier, Moaz Al Ajia, Ilona Csoti, Klaus Gehring, Gabriel Gonzalez Escamilla, Damian M. Herz, Markus Leisse, Leonore Köhler, Thea-Marie Krause, Daniel Martens, Uwe Meier, Maike Scheipers, Julia Schiffer, Nils Schröter, Rieke Schulz, Stefan Specht, Manfred Erbsland, Renate Stemmer, Sergiu Groppa
Institutions: Johannes Gutenberg University Mainz, University Medical Center of the Johannes Gutenberg University Mainz, Universitätsklinikum des Saarlandes, Philipps University of Marburg, University Hospital Frankfurt, Klinik Bad Bergzabern, Heidelberg University, University Hospital Heidelberg, Ludwigshafen University of Business and Society, Catholic University of Applied Sciences
Language: English
Topic: Nursing Roles and Practices
Subfield: General Health Professions
Field: Health Professions
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $2,190
Funder: Universität des Saarlandes
OpenAlex ID: W7155950827