Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score at 2-year Follow-up
NCT Number: NCT06560723
Acronym: FRAPA
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Elderly, Frail
Interventions: DIAGNOSTIC_TEST: Quality of life test
Sponsor: University Hospital, Rouen
Collaborators: Ministry of Health, France
Sex: ALL
Age: OLDER_ADULT
Enrollment: 120
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
Start Date: 2024-09-15
Completion Date: 2029-03-01

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.

Primary Outcome Measures: Evaluate the effect of implementing a personalized healthcare plan (PPS) on patient quality of life at M24, change in Study short Form -36 (SF-36) quality-of-life score between Inclusion (M0) and 2-year follow-up (M24). The SF-36 consists of 36 questions to assess quality of life related to general health. Each item is scored on a scale from 0 to 100, 0 and 100 representing the lowest and highest possible scores, 2 years
Secondary Outcome Measures: Patient quality of life at M6 and M12, Patient quality of life, measured by SF-36 score, at M0, M6 and M12. The SF-36 consists of 36 questions to assess quality of life related to general health. Each item is scored on a scale from 0 to 100, 0 and 100 representing the lowest and highest possible scores, 1 year|Emergency room visits and hospitalizations at M6, M12 and M24, Number of emergency room visits and hospital days at M6, M12 and M24, 2 years|Drug intake at M6, M12 and M24, Number of medications taken at M6, M12 and M24, 2 years|Therapeutic compliance at M6, M12 and M24, Therapeutic compliance, measured by GIRERD questionnaire score at M0, M6, M12 and M24. The GIRERD Questionnaire is a Self-questionnaire to estimate the level of compliance, namely whether the treatment is taken regularly and as prescribed. All responses are rated as "yes" or "no". One "yes" is equivalent to one point. Score = 0: Good compliance. Score = 1 or 2: Minor compliance issue. Score 3: Poor compliance., 2 years|Patient autonomy at M6, M12 and M24., Autonomy, measured by ADL score at M0, M6, M12 and M24.

- Activities of Daily Living (ADL) score helps to know if a person needs human help in the basic gestures of everyday life. A score of 6 determines the maximum level of autonomy., 2 years|Falls and patient mobility at M6, M12 and M24, Assessment of mobility measured by number of falls and SPPB (Short Physical Performance Battery) score at M0, M6, M12 and M24. The SPPB (Short Physical Performance Battery) is the sum of scores on three criteria: the balance test, the walking speed test and the chair lift test. This test is used to assess the physical performance of an individual. The addition of scores from all tests gives an overall performance score. A score below 8 is an indicator of risk for sarcopenia (or age-related muscular dystrophy), 2 years|Patient nutritional status at M6, M12 and M24, Nutritional status, measured by MNA test score at M0, M6, M12 and M24, 2 years|Patient's cognitive status at M6, M12 and M24, Cognitive status, measured by MMS score at M0, M6, M12 and M24. The Mini-Mental State Examination allows for a cognitive assessment of the patient. A score at the end of the test less than or equal to 24 points can evoke an altered state of consciousness and direct., 2 years|Patient's emotional state at M6, M12 and M24, Emotional state, measured by the 15-question GDS questionnaire score at M0, M6, M12 and M24. Geriatric Depression ScaleScore is used to identify depressive symptoms in elderly people. 0-5: normal; Score between 5 and 9: indicates a high probability of depression; Score 10 and above: almost always indicates depression., 2 years|Patient's social fragility at M6, M12 and M24, Social fragility, measured by the EPICES questionnaire score, at M0, M6, M12 and M24. The EPICES score (Evaluation of Precariousness and Health Inequalities in Examination Centers Health) is an individual indicator of poverty. The score is between 0 (absence of precariousness) and 100 (maximum of precariousness)., 2 years|Patient autonomy at M6, M12 and M24., Autonomy, measured by iADL score at M0, M6, M12 and M24.

- Instrumental Activities of Daily Living (iADL) score shows the level of autonomy of the patient: a maximum score of 8 represents a maximum autonomy and the more the score decreases, the more the level of autonomy decreases. This test is very fast to use and allows you to identify some dependencies., 2 years
Other Outcome Measures: Cost/Utility analysis at M12 and M24, All direct medical and non-medical costs will be considered from inclusion up to 24 months, and will be identified., 2 years