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Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score at 2-year Follow-up

Identifying and Managing Frailty in the Elderly in a Multiprofessional Health Home

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06560723
Acronym
FRAPA
Enrollment
120
Registered
2024-08-19
Start date
2026-06-01
Completion date
2030-06-01
Last updated
2026-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Elderly, Frail

Keywords

identifying

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.

Interventions

DIAGNOSTIC_TESTQuality 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.

Sponsors

University Hospital, Rouen
Lead SponsorOTHER
Ministry of Health, France
CollaboratorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Masking description

Non Applicable

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

Eligibility

Sex/Gender
ALL
Age
70 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the effect of implementing a personalized healthcare plan (PPS) on patient quality of life at M242 yearschange 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

Secondary

MeasureTime frameDescription
Patient quality of life at M6 and M121 yearPatient 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
Emergency room visits and hospitalizations at M6, M12 and M242 yearsNumber of emergency room visits and hospital days at M6, M12 and M24
Drug intake at M6, M12 and M242 yearsNumber of medications taken at M6, M12 and M24
Therapeutic compliance at M6, M12 and M242 yearsTherapeutic 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.
Patient autonomy at M6, M12 and M24.2 yearsAutonomy, 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.
Falls and patient mobility at M6, M12 and M242 yearsAssessment 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)
Patient nutritional status at M6, M12 and M242 yearsNutritional status, measured by MNA test score at M0, M6, M12 and M24
Patient's cognitive status at M6, M12 and M242 yearsCognitive 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.
Patient's emotional state at M6, M12 and M242 yearsEmotional 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.
Patient's social fragility at M6, M12 and M242 yearsSocial 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).

Countries

France

Contacts

CONTACTBlandine B BILLET, Dr
blandine.billet@wanadoo.fr06 38 12 80 25
CONTACTLucille L PELLERIN, Dr
lucepellerin@yahoo.fr06 87 44 15 63
STUDY_CHAIRLucille PELLERIN, Dr

Rouen University Department of General Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 10, 2026