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

Parkinson Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05251298
• Other study ID #: 2021-356-f-S
• Secondary ID: 01NVF19002
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2021
• Est. completion date: October 2024

Study information

• Verified date: April 2023
• Source: University Hospital Muenster
• Contact: Tessa Huchtemann, Medical Degree
• Phone: 004915254956565
• Email: Tessa.Huchtemann[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: October 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Germany	Universitätsklinikum Münster, Klinik für Neurologie	Münster	NRW

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital Muenster	AOK PLUS, privates Institut für angewandte Versorgungsforschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Change from Baseline PDQ 39 at 12 months
Secondary	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 from Baseline FIMA at 12 months
Secondary	Change in disease severity measured by UPDRS	UPDRS - Unified Parkinson's Disease Rating Scale, max. score of 199 points indicates the worst outcome	Change from Baseline UPDRS at 12 months
Secondary	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 from Baseline UPDRS at 12 months
Secondary	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.	Change from Baseline Schwab-&England-Scale at 12 months