AgingPEPSNCT04522401
Performance Evaluation Platform for Seniors.
An observational study of Aging, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- consultation: "Bien vieillir"
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2018to 31 Oct 2020
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: seniors who have had a gerontological assessment
Who may be able to join
- Person affiliated or entitled to a social security scheme
- People aged 65 and over who participated in a consultation to age well at the day hospital of the St-Etienne university hospital during the study period.
- Elderly people who received an information about the study and who co-signed, with the investigator, a consent to participate in the study
Who cannot join
- Seniors who refused to participate
- Elderly people under legal protection measures
- Severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42270
About this study
Official title: Prevention of the Loss of Autonomy in the Old People: Factors Favoring or Limiting the Respect of Recommendations
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.
Read the detailed description
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.
The main objective is to investigate the factors limiting or encouraging adherence to recommendations in a population aged over 65, fragile or pre-fragile, autonomous and living at home or in a shelter.
Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.
Patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day at the day hospital, then at 6 and 9 months. The study will take place over a period of approximately 24 months.
- Conditions
- Aging
- Being tested
- consultation: "Bien vieillir"
- Keywords
- old people, gerontological assessment, loss of autonomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
consultation: "Bien vieillir"Diagnostic test
Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.Then, patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day, then at 6 and 9 months.
| Study group | Role | What they receive |
|---|---|---|
| People aged 65 and over | People aged 65 and over who have had a gerontological evaluation "Bien vieillir" at the St-Etienne University Hospital Day Hospital. Receives: Diagnostic Test: consultation: "Bien vieillir" |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of implementation of recommendations concerning mobility (adapted physical activity).
This rate is the ratio between the number of mobility recommendations made at 9 months and the number initially recommended.
Analysis by tracking sheet patient results.
Measured: Months: 9
Secondary outcomes (2)
Overall rate of implementation of the recommendations at 9 months
Analysis by tracking sheet patient results.
Measured: Months: 9
Satisfaction rate of the platform's users
Analysis by qualitative interviews results.
Measured: Months: 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start5 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain JUGAND, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522401
- Sponsor's protocol ID
- 2018-A01075-50 (RIPH3)
- Other IDs
- 2018-A01075-50
- Acronym
- PEPS
- Status last verified
- Nov 2020
- First submitted
- 22 Jul 2020
- Last updated
- 13 Nov 2020
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of the Loss of Autonomy in the Old People: Factors Favoring or Limiting the Respect of Recommendations
- ClinicalTrials.gov ID
- NCT04522401
- Acronym / sponsor ID
- PEPS / 2018-A01075-50 (RIPH3)
- Conditions
- Aging
- Keywords
- old people, gerontological assessment, loss of autonomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 21 Aug 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.
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.
Detailed description
Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.
The main objective is to investigate the factors limiting or encouraging adherence to recommendations in a population aged over 65, fragile or pre-fragile, autonomous and living at home or in a shelter.
Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.
Patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day at the day hospital, then at 6 and 9 months. The study will take place over a period of approximately 24 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| People aged 65 and over | – | Diagnostic Test: consultation: "Bien vieillir"People aged 65 and over who have had a gerontological evaluation "Bien vieillir" at the St-Etienne University Hospital Day Hospital. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- seniors who have had a gerontological assessment
Key inclusion criteria (3 listed)
- Person affiliated or entitled to a social security scheme
- People aged 65 and over who participated in a consultation to age well at the day hospital of the St-Etienne university hospital during the study period.
- Elderly people who received an information about the study and who co-signed, with the investigator, a consent to participate in the study
Key exclusion criteria (3 listed)
- Seniors who refused to participate
- Elderly people under legal protection measures
- Severe cognitive impairment
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 |
|---|---|---|
| consultation: "Bien vieillir"Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.Then, patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day, then at 6 and 9 months. | Diagnostic test | People aged 65 and over |
Primary outcome
rate of implementation of recommendations concerning mobility (adapted physical activity).
Time frame: Months: 9
This rate is the ratio between the number of mobility recommendations made at 9 months and the number initially recommended. Analysis by tracking sheet patient results.
2 secondary outcomes
Overall rate of implementation of the recommendations at 9 months
Time frame: Months: 9
Satisfaction rate of the platform's users
Time frame: Months: 9
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 13 Nov 2020.
- Individual participant dataSharing planned: No
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Aging
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.
Romain JUGAND, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
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 Aging, run by Centre Hospitalier Universitaire de Saint Etienne 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 3 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: finished, as of the sponsor's last update on 13 Nov 2020. 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?
rate of implementation of recommendations concerning mobility (adapted physical activity). (time frame: Months: 9). 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 13 Nov 2020.