Parkinson DiseaseECOSO-ICAREPDNCT04485468
Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers
An observational study of Parkinson Disease, run by University Hospital, Toulouse at 1 site in France.
Trial summary
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients. It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Questionnaire
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2021to 2 Jul 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease patients and over 18 years old
Who may be able to join
- Patients with Parkinson's disease of any stage of severity
- Patients over 18 years of age
- Patients living at home
- Patient consultant at the expert center Parkinson's at Toulouse University Hospital
Who cannot join
- Pregnant and lactating woman
- Patient under guardianship, curatorship or safeguard of justice
- Person who does not understand French to be able to answer the questionnaire
- Patient who participated or participated in the iCare PD project
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease Patients
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.
It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.
Read the detailed description
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients
The coordination of the care pathway for patients with Parkinson disease has been improved since the implementation on the national territory of 7 interregional coordination centers and 25 regional expert centers in 2012.
Health insurance reimburses 100% of direct medical and non-medical care as soon as patients are registered in Long-Term Condition n°16. However, we currently have little information about care that is not recognized for financial coverage by health insurance.
It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.
- Conditions
- Parkinson Disease
- Being tested
- Questionnaire
- Keywords
- Parkinson Disease,, Socio-economic
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Parkinson's disease patients and over 18 years old Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the economic barriers to an optimal care path
It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.
Measured: Day 0
Secondary outcomes (2)
Identify and quantify the cost of the care pathway for patients with Parkinson's disease
it is the quantification of the number of resources consumed and identification of the unit costs for each type of resources consumed.
Measured: Day 0
identify socio-economic determinants
identify the socio-economic and territorial determinants that could have an impact on an optimal care path.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start12 Feb 2021
- Primary completion2 Jul 2021
- Study completion2 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Rascol, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485468
- Sponsor's protocol ID
- RC31/20/0184
- Acronym
- ECOSO-ICAREPD
- Status last verified
- Jun 2023
- First submitted
- 21 Jul 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Parkinson Care Networks: Assessment of Economics and Socials Barriers to the Optimal Care Pathway for Parkinson Disease Patients
- ClinicalTrials.gov ID
- NCT04485468
- Acronym / sponsor ID
- ECOSO-ICAREPD / RC31/20/0184
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease,, Socio-economic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 2 Jul 2021 (actual)
- Study completion
- 2 Jul 2021 (actual)
- First posted
- 24 Jul 2020 (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.
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients.
It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.
Detailed description
According to the latest public health report in France, Parkinson's disease (PD) affects around 160,000 patients
The coordination of the care pathway for patients with Parkinson disease has been improved since the implementation on the national territory of 7 interregional coordination centers and 25 regional expert centers in 2012.
Health insurance reimburses 100% of direct medical and non-medical care as soon as patients are registered in Long-Term Condition n°16. However, we currently have little information about care that is not recognized for financial coverage by health insurance.
It is therefore essential to estimate the overall consumption of medical and non-medical resources by patients with PD in order to characterize the share of medical and non-medical care reimbursed by health insurance, the share of medical and non-medical care not reimbursed. by health insurance, as well as the share of formal and informal care in order to identify potential economic barriers to an optimal care path for patients with PD. It is also necessary to have information on the socio-economic characteristics and the place of residence of the resident in order to estimate the impact of these determinants on an optimal course of care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | Other: QuestionnaireParkinson's disease patients and over 18 years old |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease patients and over 18 years old
Key inclusion criteria (4 listed)
- Patients with Parkinson's disease of any stage of severity
- Patients over 18 years of age
- Patients living at home
- Patient consultant at the expert center Parkinson's at Toulouse University Hospital
Key exclusion criteria (4 listed)
- Pregnant and lactating woman
- Patient under guardianship, curatorship or safeguard of justice
- Person who does not understand French to be able to answer the questionnaire
- Patient who participated or participated in the iCare PD project
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 |
|---|---|---|
| QuestionnaireThe patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later. | Other | Parkinson's disease patients |
Primary outcome
Identify the economic barriers to an optimal care path
Time frame: Day 0
It is the collection of the number of resources consumed and the remainder to be borne by the patient as well as the number of hours of informal help that will be valued using the replacement cost approach.
2 secondary outcomes
Identify and quantify the cost of the care pathway for patients with Parkinson's disease
Time frame: Day 0
identify socio-economic determinants
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Olivier Rascol principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Toulouse 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 22 Jun 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the economic barriers to an optimal care path (time frame: Day 0). 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 22 Jun 2023.