Back to results"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network" (ParkinsonAKTIV)
Primary Purpose
Parkinson Disease
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Coordination through the online platform "JamesAKTIV"
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease focused on measuring Activities of Daily Living, Disease Management, Quality of Life, Rehabilitation, Patient-Centered Care, Delivery of Health Care, Integrated Care
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
Sites / Locations
- Universitätsklinikum Münster, Klinik für NeurologieRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention group
Control group
Arm Description
Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.
Patients in the control group will undergo their usual therapies as prescribed by their neurologists.
Outcomes
Primary Outcome Measures
Change in Quality of Life measured by PDQ 39
The Parkinson's Disease Questionnaire (PDQ-39, max. score of 100 indicates the worst quality of life)
Secondary Outcome Measures
Change in Health-related resource use in the elderly population, assessed by FIMA
FIMA stands for "Questionnaire concerning Health-related resource use in the elderly population" and is a German questionnaire assessing the Health-related resource use in the elderly population
Change in disease severity measured by UPDRS
UPDRS - Unified Parkinson's Disease Rating Scale, max. score of 199 points indicates the worst outcome
Change in disease severity measured by Hoehn & Yahr
Hoehn & Yahr is a simple scale that describes disease severity on a scale of 0-5, with 5 indicating severe disability
Change in mobility, measured by Schwab- & England-Scale
Schwab- & England-Scale assesses the capabilities of people with impaired mobility. The scale uses percentages with 100% indicating full independence.
Full Information
NCT ID
NCT05251298
First Posted
December 9, 2021
Last Updated
April 18, 2023
Sponsor
University Hospital Muenster
Collaborators
privates Institut für angewandte Versorgungsforschung GmbH, AOK PLUS
1. Study Identification
Unique Protocol Identification Number
NCT05251298
Brief Title
"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"
Acronym
ParkinsonAKTIV
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 28, 2021 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Muenster
Collaborators
privates Institut für angewandte Versorgungsforschung GmbH, AOK PLUS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Activities of Daily Living, Disease Management, Quality of Life, Rehabilitation, Patient-Centered Care, Delivery of Health Care, Integrated Care
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
370 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients in the control group will undergo their usual therapies as prescribed by their neurologists.
Intervention Type
Other
Intervention Name(s)
Coordination through the online platform "JamesAKTIV"
Intervention Description
Coordination of the treatment through the online platform "JamesAKTIV" that allows neurologists and therapists to select specialised therapies for the predominant symptoms of the patients and communicate easily about problems during the treatment
Primary Outcome Measure Information:
Title
Change in Quality of Life measured by PDQ 39
Description
The Parkinson's Disease Questionnaire (PDQ-39, max. score of 100 indicates the worst quality of life)
Time Frame
Change from Baseline PDQ 39 at 12 months
Secondary Outcome Measure Information:
Title
Change in Health-related resource use in the elderly population, assessed by FIMA
Description
FIMA stands for "Questionnaire concerning Health-related resource use in the elderly population" and is a German questionnaire assessing the Health-related resource use in the elderly population
Time Frame
Change from Baseline FIMA at 12 months
Title
Change in disease severity measured by UPDRS
Description
UPDRS - Unified Parkinson's Disease Rating Scale, max. score of 199 points indicates the worst outcome
Time Frame
Change from Baseline UPDRS at 12 months
Title
Change in disease severity measured by Hoehn & Yahr
Description
Hoehn & Yahr is a simple scale that describes disease severity on a scale of 0-5, with 5 indicating severe disability
Time Frame
Change from Baseline UPDRS at 12 months
Title
Change in mobility, measured by Schwab- & England-Scale
Description
Schwab- & England-Scale assesses the capabilities of people with impaired mobility. The scale uses percentages with 100% indicating full independence.
Time Frame
Change from Baseline Schwab-&England-Scale at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tessa Huchtemann, Medical Degree
Phone
004915254956565
Email
Tessa.Huchtemann@ukmuenster.de
First Name & Middle Initial & Last Name or Official Title & Degree
Tobias Warnecke, Medical Degree, PhD
Phone
00492518345314
Email
Tobias.Warnecke@ukmuenster.de
Facility Information:
Facility Name
Universitätsklinikum Münster, Klinik für Neurologie
City
Münster
State/Province
NRW
ZIP/Postal Code
48149
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tessa Huchtemann, Medical Degree
Phone
004915254956565
Email
Tessa.Huchtemann@ukmuenster.de
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"
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