Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network (INSPIRE-PNRM)

July 18, 2025 updated by: Sergiu Groppa, Johannes Gutenberg University Mainz

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1354

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Homburg, Germany
        • Recruiting
        • Universtity of Saarland, Campus Homburg, Dept. of Neurology
        • Contact:
      • Mainz, Germany, 55131
        • Recruiting
        • INSPIRE-PNRM+ Neuroimaging Center (NIC) University Medical Center of the Johannes Gutenberg University Mainz
        • Principal Investigator:
          • Sergiu Groppa
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Interventional group
New intervention form
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: control group.
Standard treatment for Parkinson Disease
Other: Standard treatment
The standard treatment which all compulsory insured patients get.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
MDS-UPDRS III- to measure the differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group
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
EQ-5D-5L- to measure the differences in the change in quality of life across diseases after 12 months of observation between the intervention group and the control group
duration of the intervention: 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

June 24, 2024

First Submitted That Met QC Criteria

June 24, 2024

First Posted (Actual)

June 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 23, 2025

Last Update Submitted That Met QC Criteria

July 18, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01NVF22107
  • 2024-17454 (Registry Identifier: Ethic commission RLP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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