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

NCT06479083 | Recruiting

• 2 other identifiers: 01NVF221072024-17454
• Study Type: interventional
• Target: 1,354
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Advanced Practice Nurse, Telemedical, Interdisciplinary, cross-sector care networks and pathways.

Outcome Measures

Primary Outcomes (1)

• 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

  Parkinson´s Disease Quetionnaire -39 - to measure the differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the control group

  duration of the intervention: 24 months

Secondary Outcomes (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)

  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)

  duration of the intervention: 24 months

Study Arms (2)

Interventional group

OTHER

New intervention form

Other: New Intervention form including

control group.

OTHER

Standard treatment for Parkinson Disease

Other: Standard treatment

Interventions

New Intervention form including OTHER

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.

Interventional group

Standard treatment OTHER

The standard treatment which all compulsory insured patients get.

control group.

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• Hochschule für Wirtschaft und Gesellschaft Ludwigshafen Institut für Management, Ökonomie und Versorgung im Gesundheitsbereich: collaborator
• Katholische Hochschule Mainz Fachbereich Gesundheit und Pflege: collaborator
• Universitätsklinikum Frankfurt Zentrum der Neurologie und Neurochirurgie: collaborator
• Techniker Krankenkasse Landesvertretung Rheinland-Pfalz: collaborator
• DAK-Gesundheit Landesvertretung Rheinland-Pfalz und Saarland: collaborator

Study Sites (2)

Universtity of Saarland, Campus Homburg, Dept. of Neurology

Homburg, Germany

RECRUITING

INSPIRE-PNRM+ Neuroimaging Center (NIC) University Medical Center of the Johannes Gutenberg University Mainz

Mainz, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Sergiu Groppa, Prof.

CONTACT

+49 613117; Sergiu.Groppa@uks.eu

Franziska Beyer

CONTACT

+49 613117; inspire-info@parkinsonnetzwerk.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participants are randomized into two groups: Interventional and control group. Neither APN nor the patients know in which group they belong until the first visit.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med. Dr. h.c. Sergiu Groppa, MBA

Model Details: Study design: mixed-method approach; randomized study design. Planned intervention period: 12 months.

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: June 27, 2024
• Study Start: July 1, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 23, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)