Access to Health ServicesPASSyDroitNCT05788731
Become of Patients From the Permanent Access to Care (PASS) in Cayenne, French Guyana, Suffering From a Chronic Disease (High Blood Pressure - Diabetes) in the Common Law Schemes
An observational study of Access to Health Services and Health Disparity, Minority and Vulnerable Populations, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
Trial summary
It is an observational research, conducted at the Cayenne hospital about the future of hypertensive and/or diabetic patients after their follow-up at the Permanent Access to care (PASS). The PASS is a medico-social structure that allows access to medical monitoring and support towards common law. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Access to Health Services, Health Disparity, Minority and Vulnerable Populations, Chronic Disease
- How many people
- 120 participants
- Where
- 1 siteFrench Guiana
- Study dates
- 18 Jan 2023to 28 Feb 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Majeur patients of the PASS of CH de Cayenne with a chronic disease
Who may be able to join
- Be 18 years or older
- Past follow-up by the PASS of the Cayenne hospital for at least one chronic pathology identified as follows: hypertension, diabetes.
- The discharge and reorientation to general practitioner have happened between 1 month and 1 year prior to this study.
Who cannot join
- Patient with a psychiatric condition
- Refusing the study
Trial locations and contacts
1 site in 1 country.
About this study
It is an observational research, conducted at the Cayenne hospital about the future of hypertensive and/or diabetic patients after their follow-up at the Permanent Access to care (PASS). The PASS is a medico-social structure that allows access to medical monitoring and support towards common law. The main objective of the study is to evaluate the use of the common law system by these patients. Then the goal is to study the relationship between integration into the system and socio-demographic, medical characteristics, and understanding of health monitoring. Data will be collected by guided telephone interviews and the review of medical records.
Read the detailed description
The problems of social inequalities in access to care are major public health issues as recalled by the Regional Health Agency (ARS) of French Guiana in the Regional Health Project (PRS). French Guiana has high precariousness indicators with half of its population living below the poverty line. In addition, health indicators are often more degraded in precarious populations. Thus, in French Guiana, there is a higher rate of premature mortality, partly attributable to obesity, sedentary lifestyle, diabetes and hypertension than in mainland France. Despite an increased need for follow-up of chronic pathologies, the precarious population faces many difficulties in accessing care. The Permanent Access to Health Care (PASS) in Cayenne is a medico-social system, created to respond to these problems. The PASS allows access to monitoring of chronic diseases and support towards the common law healthcare system. Although the phenomenon of non-use of care studied in the precarious population of western French Guiana seems primarily attributable to the absence of social security. The main objective is to evaluate the use of the common law system in hypertensive or diabetic patients treated at the PASS in Cayenne. In addition, the investigators want to study the relationship between integration into the system and the socio-demographic, medical characteristics, understanding of health monitoring.
- Conditions
- Access to Health Services, Health Disparity, Minority and Vulnerable Populations, Chronic Disease, Social Security
- Keywords
- Health care system, Vulnerable Populations, Chronic Disease, social security, French Guiana
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients integrating the common law system
It is collected through telephone interviews while inclusions are carried out.
Measured: during inclusion
Secondary outcomes (3)
Study the relationship between system integration and socio-demographic, understanding characteristics
Measured: during inclusion
Study the relationship between system integration and medical, health follow-up
Measured: during inclusion
Proportion of patients resorting to one or more consultations with a general practitioner.
Measured: during inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start18 Jan 2023
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
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 Access to Health ServicesStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cayenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788731
- Sponsor's protocol ID
- PASSyDroit
- Acronym
- PASSyDroit
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rochemont DR, Lemenager P, Franck Y, Farhasmane A, Sabbah N, Nacher M. The epidemiology of acute coronary syndromes in French Guiana. Ann Cardiol Angeiol (Paris). 2021 Feb;70(1):7-12. doi: 10.1016/j.ancard.2020.09.032. Epub 2020 Oct 14.
PubMed 33067006
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Become of Patients From the Permanent Access to Care (PASS) in Cayenne, French Guyana, Suffering From a Chronic Disease (High Blood Pressure - Diabetes) in the Common Law Schemes
- ClinicalTrials.gov ID
- NCT05788731
- Acronym / sponsor ID
- PASSyDroit / PASSyDroit
- Conditions
- Access to Health Services, Health Disparity, Minority and Vulnerable Populations, Chronic Disease, Social Security
- Keywords
- Health care system, Vulnerable Populations, Chronic Disease, social security, French Guiana
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier de CayenneUniversity, hospital or other
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 29 Mar 2023 (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.
It is an observational research, conducted at the Cayenne hospital about the future of hypertensive and/or diabetic patients after their follow-up at the Permanent Access to care (PASS). The PASS is a medico-social structure that allows access to medical monitoring and support towards common law. The main objective of the study is to evaluate the use of the common law system by these patients. Then the goal is to study the relationship between integration into the system and socio-demographic, medical characteristics, and understanding of health monitoring. Data will be collected by guided telephone interviews and the review of medical records.
Detailed description
The problems of social inequalities in access to care are major public health issues as recalled by the Regional Health Agency (ARS) of French Guiana in the Regional Health Project (PRS). French Guiana has high precariousness indicators with half of its population living below the poverty line. In addition, health indicators are often more degraded in precarious populations. Thus, in French Guiana, there is a higher rate of premature mortality, partly attributable to obesity, sedentary lifestyle, diabetes and hypertension than in mainland France. Despite an increased need for follow-up of chronic pathologies, the precarious population faces many difficulties in accessing care. The Permanent Access to Health Care (PASS) in Cayenne is a medico-social system, created to respond to these problems. The PASS allows access to monitoring of chronic diseases and support towards the common law healthcare system. Although the phenomenon of non-use of care studied in the precarious population of western French Guiana seems primarily attributable to the absence of social security. The main objective is to evaluate the use of the common law system in hypertensive or diabetic patients treated at the PASS in Cayenne. In addition, the investigators want to study the relationship between integration into the system and the socio-demographic, medical characteristics, understanding of health monitoring.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Majeur patients of the PASS of CH de Cayenne with a chronic disease
Key inclusion criteria (3 listed)
- Be 18 years or older
- Past follow-up by the PASS of the Cayenne hospital for at least one chronic pathology identified as follows: hypertension, diabetes.
- The discharge and reorientation to general practitioner have happened between 1 month and 1 year prior to this study.
Key exclusion criteria (2 listed)
- Patient with a psychiatric condition
- Refusing the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The proportion of patients integrating the common law system
Time frame: during inclusion
It is collected through telephone interviews while inclusions are carried out.
3 secondary outcomes
Study the relationship between system integration and socio-demographic, understanding characteristics
Time frame: during inclusion
Study the relationship between system integration and medical, health follow-up
Time frame: during inclusion
Proportion of patients resorting to one or more consultations with a general practitioner.
Time frame: during inclusion
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 29 Mar 2023.
- Background: PubMed 33067006Rochemont DR, Lemenager P, Franck Y, Farhasmane A, Sabbah N, Nacher M. The epidemiology of acute coronary syndromes in French Guiana. Ann Cardiol Angeiol (Paris). 2021 Feb;70(1):7-12. doi: 10.1016/j.ancard.2020.09.032. Epub 2020 Oct 14.
- Samuel A, Vianney C. Les maladies chroniques touchent plus souvent les personnes modestes et réduisent davantage leur espérance de vie \| Direction de la recherche, des études, de l'évaluation et des statistiquesLink provided by the sponsor.
- Nacher M. santé globale et guyane: étude descriptive et comparative de quelques grands indicateurs / global health and french guiana: a descriptive and comparative study of some major indicators. 24 juin 2019;10.Link provided by the sponsor.
- Legendre B. Le renoncement aux soins : un phénomène aux ressorts économiques mais aussi sociaux. Rev Fr Aff Soc. 2021;(3):179-204.Link provided by the sponsor.
- Kieffer M. PrecASOG : Accès aux soins dans l'Ouest Guyanais : étude des causes de rupture thérapeutique chez les patients précaires atteints de maladie chronique. Université des Antilles; 2022Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Access to Health Services and Health Disparity, Minority and Vulnerable Populations, run by Centre Hospitalier de Cayenne at 1 site in French Guiana.
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 2 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 29 Mar 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 French Guiana. 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?
The proportion of patients integrating the common law system (time frame: during inclusion). 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 NCT05788731, 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 29 Mar 2023.