Parkinson DiseaseINSPIRE-PNRMNCT06479083
Interdisciplinary + Intersectoral Telemedicine Evaluation, Coordination + Treatment in RhineMain+ Parkinson's Network
A study testing New Intervention form including and Standard treatment in people with Parkinson Disease, run by Johannes Gutenberg University Mainz at 2 sites in Germany.
Trial summary
Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+. Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's… Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- New Intervention form including and Standard treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,354 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jul 2024to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary Parkinson's syndrome (G20.-) or atypical Parkinson's syndrome (G23.-, according to the current diagnostic criteria of the Movement Disorder Society, including the criteria of at least bradykinesia and rigidity or resting tremor must be present)
- In the care regions of Hesse and Rhineland-Palatinate
- Ability to give consent present
Who cannot join
- Severe dementia
- Severe depression
- Psychoses or other psychiatric or medical comorbidities that could affect the smooth implementation of the study protocol (e.g.
- tumor disease with limited life expectancy, need for dialysis, etc.)
- Drug or alcohol addiction
- Women who are pregnant or breastfeeding
- Simultaneous participation in another interventional treatment study
- Illiteracy or insufficient language skills
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
Universtity of Saarland, Campus Homburg, Dept. of Neurology
Homburg
Sergiu Groppa, +49 68411624 ext. 103, Sergiu.Groppa@uks.eu
- Recruiting
INSPIRE-PNRM+ Neuroimaging Center (NIC) University Medical Center of the Johannes Gutenberg University Mainz
Mainz, 55131
Franziska Beyer, +49 (0) 6131 17 ext. 7838, inspire-info@parkinsonnetzwerk.de
Selina Frühwald, +49 (0) 6131 17 ext. 7839, inspire-info@parkinsonnetzwerk.de
About this study
Official title: Interdisciplinary and Intersectoral Telemedicine Evaluation, Coordination and Treatment in the Rhine Main+ Parkinson's Network
Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+.
Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.
Read the detailed description
To effectively influence the long-term course of Parkinson´s a synergistic application of an individualized therapy program, which is tailored specifically to the symptoms and disease stages, is needed. The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. In-depth assessments of the individual disease situation of the patients will take place. Based on these assessments, an evidence-based and patient-centered treatment and care plan is developed. The treatment plans are monitored, controlled and evaluated by the APNs using audiovisual or tele medical communication. In addition, APNs are empowered to initiate treatment interventions necessary to implement clinical guidelines and standards, and to take charge of these interventions as part of delegation processes. The APNs ensure that patients are cared for in accordance with needs and guidelines in all areas of care. To this end, they offer, among other things, training in the handling of patients with Parkinson's disease for other professional groups involved in the treatment process and not only have the patients in mind, but also include relatives and the supporting team.
- Conditions
- Parkinson Disease
- Being tested
- New Intervention form including, Standard treatment
- Keywords
- Parkinson Disease, Advanced Practice Nurse, Telemedical, Interdisciplinary, cross-sector care networks and pathways.
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Intervention form includingOther
The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease.
Standard treatmentOther
The standard treatment which all compulsory insured patients get.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Other | New intervention form Receives: Other: New Intervention form including |
| control group. | Other | Standard treatment for Parkinson Disease Receives: Other: Standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39
Parkinson´s Disease Quetionnaire -39 - to measure the differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the control group
Measured: duration of the intervention: 24 months
Secondary outcomes (2)
Are there differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group measured with the MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS III)
MDS-UPDRS III- to measure the differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group
Measured: duration of the intervention: 24 months
Are there differences in the change in quality of life across diseases after 12 months of observation between the intervention and the control group measured with the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-5L)
EQ-5D-5L- to measure the differences in the change in quality of life across diseases after 12 months of observation between the intervention group and the control group
Measured: duration of the intervention: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Jan 2027 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study design: mixed-method approach; randomized study design. Planned intervention period: 12 months.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Hochschule für Wirtschaft und Gesellschaft Ludwigshafen Institut für Management, Ökonomie und Versorgung im Gesundheitsbereich, Katholische Hochschule Mainz Fachbereich Gesundheit und Pflege, Universitätsklinikum Frankfurt Zentrum der Neurologie und Neurochirurgie, Techniker Krankenkasse Landesvertretung Rheinland-Pfalz, DAK-Gesundheit Landesvertretung Rheinland-Pfalz und Saarland
- Responsible party
- Principal investigator, Sergiu Groppa, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06479083
- Sponsor's protocol ID
- 01NVF22107
- Other IDs
- 2024-17454
- Acronym
- INSPIRE-PNRM
- Status last verified
- Jul 2025
- First submitted
- 24 Jun 2024
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schneider SA, Paryjas S, Beyer F, Bach JP, Baudrexel S, Baier B, Ajia MA, Csoti I, Gehring K, Escamilla GG, Herz DM, Leisse M, Kohler L, Krause TM, Martens D, Meier U, Scheipers M, Schiffer J, Schroter N, Schulz R, Specht S, Erbsland M, Stemmer R, Groppa S. Protocol of the interdisciplinary and intersectoral randomized controlled trial in Parkinson patients in a specialized network in Germany: the INSPIRE Trial. Neurol Res Pract. 2026 Apr 27;8(1):32. doi: 10.1186/s42466-026-00476-6.
PubMed 42046148
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interdisciplinary and Intersectoral Telemedicine Evaluation, Coordination and Treatment in the Rhine Main+ Parkinson's Network
- ClinicalTrials.gov ID
- NCT06479083
- Acronym / sponsor ID
- INSPIRE-PNRM / 01NVF22107
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Advanced Practice Nurse, Telemedical, Interdisciplinary, cross-sector care networks and pathways.
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,354 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Hochschule für Wirtschaft und Gesellschaft Ludwigshafen Institut für Management, Ökonomie und Versorgung im Gesundheitsbereich, Katholische Hochschule Mainz Fachbereich Gesundheit und Pflege, Universitätsklinikum Frankfurt Zentrum der Neurologie und Neurochirurgie, Techniker Krankenkasse Landesvertretung Rheinland-Pfalz, DAK-Gesundheit Landesvertretung Rheinland-Pfalz und Saarland
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 27 Jun 2024 (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.
Project objective: To improve the health care of Parkinson's disease patients in the ParkinsonNetz RheinMain+.
Hypothesis: Through the interdisciplinary and cross- sectoral networking in a tele medical network and the coordinating function of an "advanced practice nurse" (APN) specially trained for Parkinson's disease, the process quality within the network is increased and the individual health status is positively influenced.
Detailed description
To effectively influence the long-term course of Parkinson´s a synergistic application of an individualized therapy program, which is tailored specifically to the symptoms and disease stages, is needed. The central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. In-depth assessments of the individual disease situation of the patients will take place. Based on these assessments, an evidence-based and patient-centered treatment and care plan is developed. The treatment plans are monitored, controlled and evaluated by the APNs using audiovisual or tele medical communication. In addition, APNs are empowered to initiate treatment interventions necessary to implement clinical guidelines and standards, and to take charge of these interventions as part of delegation processes. The APNs ensure that patients are cared for in accordance with needs and guidelines in all areas of care. To this end, they offer, among other things, training in the handling of patients with Parkinson's disease for other professional groups involved in the treatment process and not only have the patients in mind, but also include relatives and the supporting team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Study design: mixed-method approach; randomized study design. Planned intervention period: 12 months.
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Other | Other: New Intervention form includingNew intervention form |
| control group. | Other | Other: Standard treatmentStandard treatment for Parkinson Disease |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary Parkinson's syndrome (G20.-) or atypical Parkinson's syndrome (G23.-, according to the current diagnostic criteria of the Movement Disorder Society, including the criteria of at least bradykinesia and rigidity or resting tremor must be present)
- In the care regions of Hesse and Rhineland-Palatinate
- Ability to give consent present
Key exclusion criteria (8 listed)
- Severe dementia
- Severe depression
- Psychoses or other psychiatric or medical comorbidities that could affect the smooth implementation of the study protocol (e.g.
- tumor disease with limited life expectancy, need for dialysis, etc.)
- Drug or alcohol addiction
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 |
|---|---|---|
| New Intervention form includingThe central element of the new form of care is the implementation of a tele medical evaluation and coordination function, which controls individualized treatment processes within the network. The individualized evaluation and coordination of treatment paths is carried out within the already existing Parkinson's network RheinMain+ by a non-physician medical specialist (APN) specially trained for the indication Parkinson's disease. | Other | Interventional group |
| Standard treatmentThe standard treatment which all compulsory insured patients get. | Other | control group. |
Primary outcome
Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39
Time frame: duration of the intervention: 24 months
Parkinson´s Disease Quetionnaire -39 - to measure the differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the control group
2 secondary outcomes
Are there differences in the change in motor symptoms after 12 months of observation between the intervention group and the control group measured with the MDS-Unified Parkinson's Disease Rating Scale part III (MDS-UPDRS III)
Time frame: duration of the intervention: 24 months
Are there differences in the change in quality of life across diseases after 12 months of observation between the intervention and the control group measured with the European Quality of Life 5 Dimensions 3 Level Version (EQ-5D-5L)
Time frame: duration of the intervention: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
- Derived from this study: PubMed 42046148Schneider SA, Paryjas S, Beyer F, Bach JP, Baudrexel S, Baier B, Ajia MA, Csoti I, Gehring K, Escamilla GG, Herz DM, Leisse M, Kohler L, Krause TM, Martens D, Meier U, Scheipers M, Schiffer J, Schroter N, Schulz R, Specht S, Erbsland M, Stemmer R, Groppa S. Protocol of the interdisciplinary and intersectoral randomized controlled trial in Parkinson patients in a specialized network in Germany: the INSPIRE Trial. Neurol Res Pract. 2026 Apr 27;8(1):32. doi: 10.1186/s42466-026-00476-6.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Intervention form including and Standard treatment in people with Parkinson Disease, run by Johannes Gutenberg University Mainz at 2 sites 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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sergiu Groppa, Prof. (+49 613117 ext. 7838, Sergiu.Groppa@uks.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Are there differences in the change in Parkinson's-specific quality of life after 12 months of observation between the intervention group and the controll group- operationalized by the PDQ-39 (time frame: duration of the intervention: 24 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 NCT06479083, 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 23 Jul 2025.