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NCT Number: NCT06560723

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

"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.

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Key information

Conditions

Elderly, Frail

Age range

70 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charleval, France

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About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quality of life test

Diagnostic 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.

Primary outcomes

  1. Evaluate the effect of implementing a personalized healthcare plan (PPS) on patient quality of life at M24

    Time frame: 2 years

    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

Secondary outcomes

  1. Patient quality of life at M6 and M12

    Time frame: 1 year

    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

  2. Emergency room visits and hospitalizations at M6, M12 and M24

    Time frame: 2 years

    Number of emergency room visits and hospital days at M6, M12 and M24

  3. Drug intake at M6, M12 and M24

    Time frame: 2 years

    Number of medications taken at M6, M12 and M24

  4. Therapeutic compliance at M6, M12 and M24

    Time frame: 2 years

    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.

  5. Patient autonomy at M6, M12 and M24.

    Time frame: 2 years

    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.

  6. Falls and patient mobility at M6, M12 and M24

    Time frame: 2 years

    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)

  7. Patient nutritional status at M6, M12 and M24

    Time frame: 2 years

    Nutritional status, measured by MNA test score at M0, M6, M12 and M24

  8. Patient's cognitive status at M6, M12 and M24

    Time frame: 2 years

    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.

  9. Patient's emotional state at M6, M12 and M24

    Time frame: 2 years

    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.

  10. Patient's social fragility at M6, M12 and M24

    Time frame: 2 years

    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).

  11. Patient autonomy at M6, M12 and M24.

    Time frame: 2 years

    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.

Other outcomes

  1. Cost/Utility analysis at M12 and M24

    Time frame: 2 years

    All direct medical and non-medical costs will be considered from inclusion up to 24 months, and will be identified.

Study contacts

Contact information is provided by the study sponsor or research team.

Blandine B BILLET, Dr

CONTACT

[email protected]

06 38 12 80 25 ext. +33

Lucille L PELLERIN, Dr

CONTACT

[email protected]

06 87 44 15 63 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Collaborators

  • Ministry of Health, France

Registry information

Official study title

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

Acronym: FRAPA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 19, 2024
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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