Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network

Official title

Interdisciplinary and Intersectoral Telemedicine Evaluation, Coordination and Treatment in the Rhine Main+ Parkinson's Network

Overview

Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+. Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.

Detailed description

To effectively influence the long-term course of Parkinson´s a synergistic application of an individualized therapy program, which is tailored specifically to the symptoms and disease stages, is needed. The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. In-depth assessments of the individual disease situation of the patients will take place. Based on these assessments, an evidence-based and patient-centered treatment and care plan is developed. The treatment plans are monitored, controlled and evaluated by the APNs using audiovisual or tele medical communication. In addition, APNs are empowered to initiate treatment interventions necessary to implement clinical guidelines and standards, and to take charge of these interventions as part of delegation processes. The APNs ensure that patients are cared for in accordance with needs and guidelines in all areas of care. To this end, they offer, among other things, training in the handling of patients with Parkinson's disease for other professional groups involved in the treatment process and not only have the patients in mind, but also include relatives and the supporting team.

Interventions

• Other New Intervention form including
  The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease.
• Other Standard treatment
  The standard treatment which all compulsory insured patients get.

Primary outcome measures

• Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39 [Time frame: duration of the intervention: 24 months]

Secondary outcome measures (2)

• Are there differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group measured with the MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS III) [Time frame: duration of the intervention: 24 months]
• Are there differences in the change in quality of life across diseases after 12 months of observation between the intervention and the control group measured with the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-5L) [Time frame: duration of the intervention: 24 months]

Eligibility criteria

Inclusion criteria

• Diagnosis of primary Parkinson's syndrome (G20.-) or atypical Parkinson's syndrome (G23.-, according to the current diagnostic criteria of the Movement Disorder Society, including the criteria of at least bradykinesia and rigidity or resting tremor must be present)
• In the care regions of Hesse and Rhineland-Palatinate
• Ability to give consent present

Exclusion criteria

\- Severe dementia

• Severe depression
• Psychoses or other psychiatric or medical comorbidities that could affect the smooth implementation of the study protocol (e.g.

tumor disease with limited life expectancy, need for dialysis, etc.)

• Drug or alcohol addiction
• Women who are pregnant or breastfeeding
• Simultaneous participation in another interventional treatment study
• Illiteracy or insufficient language skills

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

Germany · 2 centers

• Universtity of Saarland, Campus Homburg, Dept. of Neurology — Homburg
• INSPIRE-PNRM+ Neuroimaging Center (NIC) University Medical Center of the Johannes Gutenber — Mainz

Publications

• Schneider SA, Paryjas S, Beyer F, Bach JP, Baudrexel S, Baier B, Ajia MA, Csoti I, Gehring K, Escamilla GG, Herz DM, Leisse M, Kohler L, Krause TM, Martens D, Meier U, Scheipers M, Schiffer J, Schroter N, Schulz R, Specht S, Erbsland M, Stemmer R, Groppa S. Protocol of the interdisciplinary and intersectoral randomized controlled trial in Parkinson patients in a specialized network in Germany: the PMID 42046148

Identifiers

NCT: NCT06479083 · 01NVF22107 · 2024-17454

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗