Clinical trial NCT05251298: "Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"
Official title: "Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"- Evaluates the Efficacy of an Online Platform That Allows Neurologists and Therapists to Exchange Therapy Recommendations Regarding Their Patients With Parkinson's Disease (PwP), Communicate Assessments and Plan Physical Therapy, Occupational Therapy as Well as Speech and Swallowing Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: Activities of Daily Living
Disease Management
Quality of Life
Rehabilitation
Patient-Centered Care
Delivery of Health Care
Integrated Care
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: privates Institut für angewandte Versorgungsforschung GmbH
name: AOK PLUS
First posted: 2022-02-22
Enrollment: 370
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to evaluate the efficacy of an online platform that allows neurologists and therapists to exchange therapy recommendations, communicate assessments and plan physical therapy, occupational therapy as well as speech and swallowing therapy for their patients.

Detailed description: The aim of this study is to enroll 185 patients in the intervention group and 185 patients in the control group. Patients in the intervention group come from the same region (Münsterland), the control group will consist of patients outside this region. The patients in the intervention group undergo therapies planned and coordinated through the online platform for 12 months. The patients in the intervention group will be evaluated using the PDQ-39, UPDRS, H\&Y as well as Schwab \& England. The patients in the control group will be evaluated using the PDQ-39.

Eligibility criteria: Inclusion Criteria (Intervention Group):

* Idiopathic Parkinson's Disease with pharmacological treatment
* 30 years old or older
* place of residence: Münsterland, Tecklenburger Land, Kreis and Stadt Osnabrück
* sufficient knowledge of the German language, should be able to understand the consent form

Exclusion Criteria:

* severe cognitive deficits
* Atypical Parkinsonian Disorders
* participation in other studies

Primary outcomes:
measure: Change in Quality of Life measured by PDQ 39
timeFrame: Change from Baseline PDQ 39 at 12 months
Secondary outcomes:
measure: Change in Health-related resource use in the elderly population, assessed by FIMA
timeFrame: Change from Baseline FIMA at 12 months
measure: Change in disease severity measured by UPDRS
timeFrame: Change from Baseline UPDRS at 12 months
measure: Change in disease severity measured by Hoehn & Yahr
timeFrame: Change from Baseline UPDRS at 12 months
measure: Change in mobility, measured by Schwab- & England-Scale
timeFrame: Change from Baseline Schwab-&England-Scale at 12 months
Other outcomes:
Locations:
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Neurologie
state: NRW
Study officials:
References: