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

Johannes Gutenberg University (JGU)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: New Intervention form including; Other: Standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06479083

2024-17454 (Registry Identifier)

01NVF22107

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,354 estimated patients

Sex: All

Ages: 30 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,354 participants in 2 patient groups

Interventional group

Other group

Description:

New intervention form

Treatment:

Other: New Intervention form including

control group.

Other group

Description:

Standard treatment for Parkinson Disease

Treatment:

Other: Standard treatment