Loss of AutonomyPAERPANCT04165915
Seniors'Health Paths " PAERPA ",
An observational study of Loss of Autonomy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan "… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Loss of Autonomy
- How many people
- 137 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2017to 30 Apr 2019
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient aged 60 and over with an individual health care plan living in the territory of East Heraultais
Who may be able to join
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged of 60 years and more
- individual health care plan was prepared
- living in the Est-Héraultais territory
Who cannot join
- Hospitalized patients
- Patients who declined to have an individual heath care planPsychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Seniors'Health Paths " PAERPA ", a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.
•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.
•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.
- Conditions
- Loss of Autonomy
- Keywords
- Aged of 60 years and more, living in the Est-Héraultais territory, seniors'health paths, PAERPA
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimating goals set by the PPS (personalized health plan)
achievement of objectives established in the individual health care plan after 6 and 12 month follow-up
Measured: 6 and 12 month follow-up
Secondary outcomes (3)
correlation between unwillingness and cognitive disorder
correlation between unwillingness and cognitive disorder
Measured: 1 day
Correlation between unwillingness and numbers of established goals
Correlation between unwillingness and numbers of established goals
Measured: 1 day
Correlation between unwillingness and locomotors goals
Correlation between unwillingness and locomotors goals
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Sep 2017
- Primary completion1 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Loss of AutonomyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chokri Boubakri, MD, Principal investigator, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04165915
- Sponsor's protocol ID
- RECHMPL19_0513
- Acronym
- PAERPA
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seniors'Health Paths " PAERPA ", a Support Being Made Available to General Practionners for Assistance in the Management of Elderly Persons at Risk of Losing Their Independence. Review of the Implementation of the Arrangement on the Est-héraultais Territory.
- ClinicalTrials.gov ID
- NCT04165915
- Acronym / sponsor ID
- PAERPA / RECHMPL19_0513
- Conditions
- Loss of Autonomy
- Keywords
- Aged of 60 years and more, living in the Est-Héraultais territory, seniors'health paths, PAERPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 18 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.
•Background: PAERPA experimentation implemented in the East-Herault region since September 2017 aims to identify fragility and prevent the risk of loss of autonomy in elderly persons older than 60 years by facilitating coordination between Professionals taking care of the patient with the personalized health plan " PPS". The main objective of this study was to evaluate the implementation of this device through the achievement or not of the objectives set by the PPS.
•Methods: Descriptive cohort study with retrospective inclusion and prospective follow-up from the East Herault CTA database. All patients over 60 years old living at home and having a PPS written between September 2017 and April 2018 were included. PPS monitoring for 1 year. Description of this population then analysis of PPS.
•Discussion: Our study aims to evaluate the implementation of the device to identify ways to improve the device for the management of subjects at risk of loss of autonomy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient aged 60 and over with an individual health care plan living in the territory of East Heraultais
Key inclusion criteria (4 listed)
- An individual must fulfill all of the following criteria in order to be eligible for study enrollment:
- Aged of 60 years and more
- individual health care plan was prepared
- living in the Est-Héraultais territory
Key exclusion criteria (2 listed)
- Hospitalized patients
- Patients who declined to have an individual heath care planPsychosis
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
Estimating goals set by the PPS (personalized health plan)
Time frame: 6 and 12 month follow-up
achievement of objectives established in the individual health care plan after 6 and 12 month follow-up
3 secondary outcomes
correlation between unwillingness and cognitive disorder
Time frame: 1 day
Correlation between unwillingness and numbers of established goals
Time frame: 1 day
Correlation between unwillingness and locomotors goals
Time frame: 1 day
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 18 Nov 2019.
- Individual participant dataSharing planned: Undecided. NC
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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.
Chokri Boubakri, MD principal investigator
University Hospitals of Montpellier
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 Loss of Autonomy, run by University Hospital, Montpellier 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 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 18 Nov 2019. 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?
Estimating goals set by the PPS (personalized health plan) (time frame: 6 and 12 month follow-up). 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 18 Nov 2019.