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RecruitingNCT06479083INSPIRE-PNRMUpdated Jul 23, 2025

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

An interventional study of New Intervention form including and Standard treatment in Parkinson Disease, sponsored by Johannes Gutenberg University Mainz. Recruiting at 2 sites in Germany. Open to participants aged 30 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-07-23.

Sponsored by Johannes Gutenberg University Mainz · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
1,354
Allocation
Randomized
Ages
30 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

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Keywords

  • Parkinson Disease, Advanced Practice Nurse, Telemedical, Interdisciplinary, cross-sector care networks and pathways.
03

Who can participate

Ages eligible
30 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
1,354 participants (estimated)

Study arms

  • Other
    Interventional group

    New intervention form

    Other: New Intervention form including

  • Other
    control group.

    Standard treatment for Parkinson Disease

    Other: Standard treatment

Interventions

  • OtherNew 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.

  • OtherStandard treatment

    The standard treatment which all compulsory insured patients get.

05

What researchers measure

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

    Time frame: duration of the intervention: 24 months

Secondary outcomes

  1. 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)

    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

    Time frame: duration of the intervention: 24 months

  2. 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)

    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

    Time frame: duration of the intervention: 24 months

06

Study locations

2 of 2 sites recruiting
  • 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
07

References and documents

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 INSPIRE Trial. Neurol Res Pract. 2026 Apr 27;8(1):32. doi: 10.1186/s42466-026-00476-6. PubMed 42046148 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06479083
Lead 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
Responsible party
Sergiu Groppa (Univ.-Prof. Dr. med. Dr. h.c. Sergiu Groppa, MBA, Johannes Gutenberg University Mainz) — Principal investigator
First posted
Jun 27, 2024
Start date
Jul 1, 2024
Primary completion
Oct 31, 2025 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
Jul 23, 2025

Study contacts

Sergiu Groppa, Prof.
Contact
Sergiu.Groppa@uks.eu
+49 613117 ext. 7838
Franziska Beyer
Contact
inspire-info@parkinsonnetzwerk.de
+49 613117 ext. 7839

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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