Parkinson DiseaseParkinsonAKTIVNCT05251298
"Parkinson AKTIV - Non-pharmacological Treatments in an Innovative Parkinson's Network"
A study testing Coordination through the online platform "JamesAKTIV" in people with Parkinson Disease, run by University Hospital Muenster at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Coordination through the online platform "JamesAKTIV"
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteGermany
- Study dates
- 28 Nov 2021to Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cognitive deficits
- Atypical Parkinsonian Disorders
- participation in other studies
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitätsklinikum Münster, Klinik für Neurologie
Münster, North Rhine-Westphalia, 48149
Tessa Huchtemann, Medical Degree, 004915254956565, Tessa.Huchtemann@ukmuenster.de
About this study
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
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Coordination through the online platform "JamesAKTIV"
- Keywords
- Activities of Daily Living, Disease Management, Quality of Life, Rehabilitation, Patient-Centered Care, Delivery of Health Care, Integrated Care
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordination through the online platform "JamesAKTIV"Other
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform. Receives: Other: Coordination through the online platform "JamesAKTIV" |
| Control group | No intervention | Patients in the control group will undergo their usual therapies as prescribed by their neurologists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Change from Baseline PDQ 39 at 12 months
Secondary outcomes (4)
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
Measured: Change from Baseline FIMA at 12 months
Change in disease severity measured by UPDRS
UPDRS - Unified Parkinson's Disease Rating Scale, max. score of 199 points indicates the worst outcome
Measured: Change from Baseline UPDRS at 12 months
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
Measured: Change from Baseline UPDRS at 12 months
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.
Measured: Change from Baseline Schwab-&England-Scale at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start28 Nov 2021
- Primary completionMar 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- privates Institut für angewandte Versorgungsforschung GmbH, AOK PLUS
- Responsible party
- Principal investigator, Dr. Tobias Warnecke, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05251298
- Sponsor's protocol ID
- 2021-356-f-S
- Other IDs
- 01NVF19002
- Acronym
- ParkinsonAKTIV
- Status last verified
- Apr 2023
- First submitted
- 9 Dec 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Achtert K, Huchtemann T, Altendorf M, Kerkemeyer L, Haring M, Lummer C, Frenz L, Becking T, Friedmann J, Mildner P, Schwarze K, Steinhaus L, Amelung V, Warnecke T. Design and implementation of ParkinsonAKTIV: an interventional study to evaluate the effectiveness of a novel online platform to guide quickcard-based treatment decisions. Neurol Res Pract. 2023 Jun 1;5(1):23. doi: 10.1186/s42466-023-00249-5.
PubMed 37259124
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05251298
- Acronym / sponsor ID
- ParkinsonAKTIV / 2021-356-f-S
- Conditions
- Parkinson Disease
- Keywords
- Activities of Daily Living, Disease Management, Quality of Life, Rehabilitation, Patient-Centered Care, Delivery of Health Care, Integrated Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- privates Institut für angewandte Versorgungsforschung GmbH, AOK PLUS
- Study start
- 28 Nov 2021 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Coordination through the online platform "JamesAKTIV"Patients in the intervention group come from the same region (Münsterland) and will undergo therapies coordinated through the online platform. |
| Control group | No intervention | –Patients in the control group will undergo their usual therapies as prescribed by their neurologists. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- severe cognitive deficits
- Atypical Parkinsonian Disorders
- participation in other studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Intervention group |
Primary outcome
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)
4 secondary outcomes
Change in Health-related resource use in the elderly population, assessed by FIMA
Time frame: Change from Baseline FIMA at 12 months
Change in disease severity measured by UPDRS
Time frame: Change from Baseline UPDRS at 12 months
Change in disease severity measured by Hoehn & Yahr
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
- Derived from this study: PubMed 37259124Achtert K, Huchtemann T, Altendorf M, Kerkemeyer L, Haring M, Lummer C, Frenz L, Becking T, Friedmann J, Mildner P, Schwarze K, Steinhaus L, Amelung V, Warnecke T. Design and implementation of ParkinsonAKTIV: an interventional study to evaluate the effectiveness of a novel online platform to guide quickcard-based treatment decisions. Neurol Res Pract. 2023 Jun 1;5(1):23. doi: 10.1186/s42466-023-00249-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordination through the online platform "JamesAKTIV" in people with Parkinson Disease, run by University Hospital Muenster at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tessa Huchtemann, Medical Degree (004915254956565, Tessa.Huchtemann@ukmuenster.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of Life measured by PDQ 39 (time frame: Change from Baseline PDQ 39 at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05251298, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.