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Clinical Trials/NCT06479083
NCT06479083
Recruiting
Not Applicable

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

Johannes Gutenberg University Mainz2 sites in 1 country1,354 target enrollmentJuly 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Johannes Gutenberg University Mainz
Enrollment
1354
Locations
2
Primary Endpoint
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
Status
Recruiting
Last Updated
9 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
January 31, 2027
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Johannes Gutenberg University Mainz
Responsible Party
Principal Investigator
Principal Investigator

Sergiu Groppa

Univ.-Prof. Dr. med. Dr. h.c. Sergiu Groppa, MBA

Johannes Gutenberg University Mainz

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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 Sites (2)

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