"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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 370
- Locations
- 1
- Primary Endpoint
- Change in Quality of Life measured by PDQ 39
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 30 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention group
Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.
Intervention: Coordination through the online platform "JamesAKTIV" (Other)
Control group
Patients in the control group will undergo their usual therapies as prescribed by their neurologists.
Outcomes
Primary Outcomes
Change in Quality of Life measured by PDQ 39
Time Frame: Change from Baseline PDQ 39 at 12 months
The Parkinson's Disease Questionnaire (PDQ-39, max. score of 100 indicates the worst quality of life)
Secondary Outcomes
- Change in disease severity measured by Hoehn & Yahr(Change from Baseline UPDRS at 12 months)
- Change in mobility, measured by Schwab- & England-Scale(Change from Baseline Schwab-&England-Scale at 12 months)
- Change in disease severity measured by UPDRS(Change from Baseline UPDRS at 12 months)
- Change in Health-related resource use in the elderly population, assessed by FIMA(Change from Baseline FIMA at 12 months)
Investigators
Dr. Tobias Warnecke
Professor Dr. Tobias Warnecke
University Hospital Muenster