"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network" (ParkinsonAKTIV)

April 18, 2023 updated by: Dr. Tobias Warnecke, University Hospital Muenster

"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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

370

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • NRW
      • Münster, NRW, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster, Klinik für Neurologie
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention group
Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform.
Other: Coordination through the online platform "JamesAKTIV"
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
No Intervention: Control group
Patients in the control group will undergo their usual therapies as prescribed by their neurologists.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Change from Baseline PDQ 39 at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Health-related resource use in the elderly population, assessed by FIMA
Time Frame: Change from Baseline FIMA at 12 months
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 from Baseline FIMA at 12 months
Change in disease severity measured by UPDRS
Time Frame: Change from Baseline UPDRS at 12 months
UPDRS - Unified Parkinson's Disease Rating Scale, max. score of 199 points indicates the worst outcome
Change from Baseline UPDRS at 12 months
Change in disease severity measured by Hoehn & Yahr
Time Frame: Change from Baseline UPDRS at 12 months
Hoehn & Yahr is a simple scale that describes disease severity on a scale of 0-5, with 5 indicating severe disability
Change from Baseline UPDRS at 12 months
Change in mobility, measured by Schwab- & England-Scale
Time Frame: Change from Baseline Schwab-&England-Scale at 12 months
Schwab- & England-Scale assesses the capabilities of people with impaired mobility. The scale uses percentages with 100% indicating full independence.
Change from Baseline Schwab-&England-Scale at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

AOK PLUS
privates Institut für angewandte Versorgungsforschung GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2021

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

October 1, 2024

Study Registration Dates

First Submitted

December 9, 2021

First Submitted That Met QC Criteria

February 11, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-356-f-S
  • 01NVF19002 (Other Grant/Funding Number: Gemeinsamer Bundesausschuss; Innovationsausschuss)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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