Parkinson's DiseasePARKINSUNNCT04179695
Evaluation of a New Communication Aid Tool to Favor Global Patient Centered Care
A study testing Consulting with PARKINSUN as communication aid-tool and Consulting without PARKINSUN as communication aid-tool in people with Parkinson's Disease, run by University Hospital, Lille at 1 site in France.
Trial summary
PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Consulting with PARKINSUN as communication aid-tool and Consulting without PARKINSUN as communication aid-tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jul 2020to Dec 2026
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men and women with all stages of PD
- Without severe chronic neurological or mental or psychiatric pathology
- Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA > 22)
- able to come (alone or accompanied) to consultation
- Affiliate or beneficiary of a social security scheme
- Subject having signed informed consent
- Patient willing to comply with all procedures of the study and its duration
Who cannot join
- Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
- Subject under tutelage or curtailer.
- Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Roger Salengro, CHU Lille
Lille, 59037
0320445962
About this study
Official title: Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN
PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.
- Conditions
- Parkinson's Disease
- Being tested
- Consulting with PARKINSUN as communication aid-tool, Consulting without PARKINSUN as communication aid-tool
- Keywords
- Health pathway, patient centered care, communication aid- tool, primary care, secondary 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.
Consulting with PARKINSUN as communication aid-toolOther
Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months
Consulting without PARKINSUN as communication aid-toolOther
Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months
| Study group | Role | What they receive |
|---|---|---|
| consultation with Parkinsun | Experimental | Not described Receives: Other: Consulting with PARKINSUN as communication aid-tool |
| consultation as usual without Parkinsun | Active comparator | Not described Receives: Other: Consulting without PARKINSUN as communication aid-tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation of the delta of G-MISS Questionnaire
Measured: at 7 months
Secondary outcomes (7)
G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)
Patient's satisfaction will be assessed by the G-MISS-Questionnaire. The G-MISS questionnaire is a standardized and validated tool in French. This questionnaire is taken from the American MISS-21 questionnaire, already used in neurologists to measure the satisfaction of patients with PD, after consultation It is easy to use with an average filling time of 6 minutes.
Measured: at the end of each consultation (1 month and 7 months)
Global score of PARKINSUN
Measured: at the end of each consultation ((1 month and 7 months)
Individuals scores of PARKINSUN
Measured: at the end of each consultation ((1 month and 7 months)
MDS-UPDRS scores
Measured: at the end of each consultation ((1 month and 7 months)
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)
Measured: at the end of each consultation ((1 month and 7 months)
Likert Scale
Measured: at the end of each consultation (1 month and 7 months)
Interpersonal Reactivity Index (IRI)
Measured: at the end of each consultation (1 month and 7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start21 Jul 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Expert center of Parkinson's Disease (CHU Lille), College of teaching general practitioners (CEMG Lille), Regional Health Agency (ARS), UCB Pharma, Orkyn'
- Responsible party
- Sponsor
- Investigators
- David Devos, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04179695
- Sponsor's protocol ID
- 2018_74
- Other IDs
- 2019-A01008-49
- Acronym
- PARKINSUN
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2019
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing PD Patient's Health Pathways: Favoring Global, Patient Centered Care by a New Communication Aid Tool PARKINSUN
- ClinicalTrials.gov ID
- NCT04179695
- Acronym / sponsor ID
- PARKINSUN / 2018_74
- Conditions
- Parkinson's Disease
- Keywords
- Health pathway, patient centered care, communication aid- tool, primary care, secondary care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Expert center of Parkinson's Disease (CHU Lille), College of teaching general practitioners (CEMG Lille), Regional Health Agency (ARS), UCB Pharma, Orkyn'
- Study start
- 21 Jul 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Nov 2019 (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.
PARKINSUN is a new communication aid tool, expected to favor global patient centered care for PD patients during consultation with GPs and neurologists. Two groups of patients will be randomized to use or not PARKINSUN when they consult their physicians every 3 months during 7 months.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| consultation with Parkinsun | Experimental | Other: Consulting with PARKINSUN as communication aid-tool |
| consultation as usual without Parkinsun | Active comparator | Other: Consulting without PARKINSUN as communication aid-tool |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult men and women with all stages of PD
- Without severe chronic neurological or mental or psychiatric pathology
- Absence of cognitive impairment affecting autonomy (MDS criteria of dementia and MOCA > 22)
- able to come (alone or accompanied) to consultation
- Affiliate or beneficiary of a social security scheme
Key exclusion criteria (3 listed)
- Administrative reasons: impossibility of receiving informed information, inability to participate in the whole study, absence of coverage by the social security system, refusal to sign consent.
- Subject under tutelage or curtailer.
- Subject not fluent in the French language to understand the instructions necessary to carry out the cognitive tests.
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 |
|---|---|---|
| Consulting with PARKINSUN as communication aid-toolParticipating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months | Other | consultation with Parkinsun |
| Consulting without PARKINSUN as communication aid-toolParticipating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months | Other | consultation as usual without Parkinsun |
Primary outcome
variation of the delta of G-MISS Questionnaire
Time frame: at 7 months
7 secondary outcomes
G-MISS-Questionnaire at the end of each consultation (1 month, 4 months and 7 months)
Time frame: at the end of each consultation (1 month and 7 months)
Global score of PARKINSUN
Time frame: at the end of each consultation ((1 month and 7 months)
Individuals scores of PARKINSUN
Time frame: at the end of each consultation ((1 month and 7 months)
MDS-UPDRS scores
Time frame: at the end of each consultation ((1 month and 7 months)
PDQ-39 scores 6. Interpersonal Reactivity Index (IRI)
Time frame: at the end of each consultation ((1 month and 7 months)
Likert Scale
Time frame: at the end of each consultation (1 month and 7 months)
Interpersonal Reactivity Index (IRI)
Time frame: at the end of each consultation (1 month and 7 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 Dec 2025.
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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.
David Devos principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Consulting with PARKINSUN as communication aid-tool and Consulting without PARKINSUN as communication aid-tool in people with Parkinson's Disease, run by University Hospital, Lille at 1 site in France.
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 7 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. 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 France. 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 David Devos, MD,PhD (03 20 44 54 49 ext. +33, david.devos@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation of the delta of G-MISS Questionnaire (time frame: at 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.