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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04522401
Other study ID # 2018-A01075-50 (RIPH3)
Secondary ID 2018-A01075-50
Status Completed
Phase
First received
Last updated
Start date March 5, 2018
Est. completion date October 31, 2020

Study information

Verified date November 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date October 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Seniors who refused to participate - Elderly people under legal protection measures - Severe cognitive impairment

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
France Centre Hospitalier Universitaire de Saint-Etienne Saint-Étienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
Months: 9
Secondary Overall rate of implementation of the recommendations at 9 months Analysis by tracking sheet patient results. Months: 9
Secondary Satisfaction rate of the platform's users Analysis by qualitative interviews results. Months: 9
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