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

NCT06560723 | Not Yet Recruiting

• 2 other identifiers: 2022/0348/HP2023-A02358-37
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Elderly, Frail

Keywords

identifying

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Patient quality of life at M6 and M12

  1 year

• Emergency room visits and hospitalizations at M6, M12 and M24

  2 years

• Drug intake at M6, M12 and M24

  2 years

• Therapeutic compliance at M6, M12 and M24

  2 years

• Patient autonomy at M6, M12 and M24.

  2 years

Other Outcomes (1)

• Cost/Utility analysis at M12 and M24

  2 years

Study Arms (2)

Group 1 Interventional Arm (with PHP)

OTHER

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.

Diagnostic Test: Quality of life test

Group 2 Control Arm (without PHP)

OTHER

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.

Diagnostic Test: Quality of life test

Interventions

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.

Group 1 Interventional Arm (with PHP); Group 2 Control Arm (without PHP)

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Rouen: lead
• Ministry of Health, France: collaborator

Study Officials

• Lucille PELLERIN, Dr

  Rouen University Department of General Medicine

  STUDY CHAIR

Central Study Contacts

Blandine B BILLET, Dr

CONTACT

06 38 12 80 25; blandine.billet@wanadoo.fr

Lucille L PELLERIN, Dr

CONTACT

06 87 44 15 63; lucepellerin@yahoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Non Applicable
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: August 19, 2024
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-04