Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score At 2-year Follow-up
NCT ID: NCT06560723
Last Updated: 2024-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
120 participants
INTERVENTIONAL
2025-03-01
2029-03-01
Brief Summary
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Detailed Description
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The Gerontopole Frailty Screening Tool and the Fatigue, Resistance, Ambulation, Illness, Loss of Weight questionnaire have proved more sensitive. The gold standard for diagnosing and assessing frailty is a comprehensive geriatric assessment based on the multidimensional model of the Standardized Geriatric Assessment (SGA). Its aim is to identify all the medical, functional, psychological and social problems that may affect a frail elderly patient, in order to set up a long-term follow-up project, taking into account the patient's needs.
It is interesting to study whether the implementation of a Personal Health Plan in a Multiprofessional Health Home improves the quality of life of frail elderly people.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
For the primary endpoint, the variation in the SF-36 score between M0 and M24 will be calculated and compared between the two groups using Student's t test. This crude comparison will be supplemented by an adjusted comparison based on a linear regression model, taking into account sociodemographic and clinical characteristics deemed relevant to account for potential patient selection bias. These characteristics differ from one center to another, leading to a potential confounding bias, hence the proposed adjustment
DIAGNOSTIC
NONE
Study Groups
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Group 1 Interventional Arm (with PHP)
The patient will have a standardized geriatric assessment carried out by a nurse in both Multiprofessional Health Home. This geriatric assessment will be used to draw up a summary with different objectives and priorities, which will then be discussed at a multi-professional consultation meeting in the month following the geriatric assessment. The first multi-professional consultation meeting (MCM) will present the summary of the geriatric assessment and discuss the care and assistance to be implemented in the Personalized Health Plan (PHP). The Personalized Health Plan will then be prepared and formalized by the nurse, in partnership with the other healthcare professionals involved in the Personalized Health Plan. It will be presented to and validated by the patient and his/her carer. The actions will then be implemented.
Quality of life test
The results of the various quality-of-life scores used to compile the study statistics (ADL, iADL, MMS, GDS, MNA, EPICES, SPPB, SF-36) will be provided to the doctor, but without any specific comments or recommendations, and then presented to the patient. Number of emergency room visits and hospitalization days, drug untake evalautions and thepareutic compliance (GIRERD score) will be also collected.
Group 2 Control Arm (without PHP)
In the control group, the attending physician will set up appropriate care for a patient identified as frail in a standard general medical care pathway, having been made aware of the patient's frailty at the time of inclusion. He or she will organize the patient's care, referring him or her to the appropriate specialists according to the difficulties identified at inclusion, and according to the patient's habits and network.
Quality of life test
The results of the various quality-of-life scores used to compile the study statistics (ADL, iADL, MMS, GDS, MNA, EPICES, SPPB, SF-36) will be provided to the doctor, but without any specific comments or recommendations, and then presented to the patient. Number of emergency room visits and hospitalization days, drug untake evalautions and thepareutic compliance (GIRERD score) will be also collected.
Interventions
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Quality of life test
The results of the various quality-of-life scores used to compile the study statistics (ADL, iADL, MMS, GDS, MNA, EPICES, SPPB, SF-36) will be provided to the doctor, but without any specific comments or recommendations, and then presented to the patient. Number of emergency room visits and hospitalization days, drug untake evalautions and thepareutic compliance (GIRERD score) will be also collected.
Eligibility Criteria
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Inclusion Criteria
* Autonomous patient (ADL ≥ 5)
* Patient identified as frail according to the Gérontopôle de Toulouse GFST grid
* Patient whose primary care physician is in the MSPs of Charleval or Romilly sur Andelle for the intervention group, and in the MSPs of Gaillon and Pont de l'Arche for the control group.
* Patient living at home or in an RPA
* Understanding of the French language
* Patient having read and understood the information letter and signed the consent form
* Affiliation with a social security scheme
Exclusion Criteria
* Geriatric assessment already carried out
* Person deprived of liberty by an administrative or judicial decision, or placed under court protection / sub-guardianship or curatorship
* History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol, or from giving informed consent.
70 Years
100 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Lucille PELLERIN, Dr
Role: STUDY_CHAIR
Rouen University Department of General Medicine
Central Contacts
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Other Identifiers
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2023-A02358-37
Identifier Type: OTHER
Identifier Source: secondary_id
2022/0348/HP
Identifier Type: -
Identifier Source: org_study_id