Clinical trial NCT06560723: Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score At 2-year Follow-up
Official title: Identifying and Managing Frailty in the Elderly in a Multiprofessional Health Home
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Elderly, Frail
Keywords: identifying
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2024-08-19
Enrollment: 120
Sex: ALL
Minimum age (years): 70
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The subjects included in this study will be described globally and then by group (experimental group and control group) using the usual parameters: mean, standard deviation, median, interquartile range, extreme values for quantitative variables; frequency and cumulative frequency (if relevant) for qualitative variables.

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
Primary purpose: DIAGNOSTIC

Brief summary: "Healthy ageing" is not limited to the absence of disease, but implies the "development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being": (for example : the ability to walk, go out, engage in leisure activities, memorize...) It is interesting to study whether the implementation of a Personal Health Plan (PHP) in a Multiprofessional Health Home improves the quality of life of frail elderly people.

Detailed description: "Healthy ageing" is not limited to the absence of disease, but implies the "development and maintenance of the functional skills that enable the elderly to enjoy a state of well-being": (for example : the ability to walk, go out, engage in leisure activities, memorize...) Between "good health" and "dependence", there is a precarious, reversible state of transition known as frailty. There are several simple tools for identifying frailty, such as the GFST (Gerontopole Frailty Screening Tool).

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.

Eligibility criteria: Inclusion Criteria:

* Patient ≥ 70 years
* 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:

* Hospital geriatric follow-up
* 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.

Primary outcomes:
measure: Evaluate the effect of implementing a personalized healthcare plan (PPS) on patient quality of life at M24
timeFrame: 2 years
Secondary outcomes:
measure: Patient quality of life at M6 and M12
timeFrame: 1 year
measure: Emergency room visits and hospitalizations at M6, M12 and M24
timeFrame: 2 years
measure: Drug intake at M6, M12 and M24
timeFrame: 2 years
measure: Therapeutic compliance at M6, M12 and M24
timeFrame: 2 years
measure: Patient autonomy at M6, M12 and M24.
timeFrame: 2 years
measure: Falls and patient mobility at M6, M12 and M24
timeFrame: 2 years
measure: Patient nutritional status at M6, M12 and M24
timeFrame: 2 years
measure: Patient's cognitive status at M6, M12 and M24
timeFrame: 2 years
measure: Patient's emotional state at M6, M12 and M24
timeFrame: 2 years
measure: Patient's social fragility at M6, M12 and M24
timeFrame: 2 years
measure: Patient autonomy at M6, M12 and M24.
timeFrame: 2 years
Other outcomes:
measure: Cost/Utility analysis at M12 and M24
timeFrame: 2 years
Locations:
Study officials:
affiliation: Rouen University Department of General Medicine
name: Lucille PELLERIN, Dr
role: STUDY_CHAIR
References: