Elderly, FrailFRAPANCT06560723
Implementation of a Personalised Health Plan (PHP) on Patient Quality of Life Score at 2-year Follow-up
A study testing Quality of life test in people with Elderly, Frail, run by University Hospital, Rouen at 4 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 to 100 years
- Conditions the study is for
- Elderly, Frail
- What is being tested?
- Quality of life test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesFrance
- Study dates
- 1 Jun 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Charleval
Charleval, 27380
Blandine Billet, Dr, 02 32 4 901 17, blandine.billet1@orange.fr
Blandine Billet, Dr
GAILLON
Gaillon, 27600
Emilie Lenoble, Dr, 02 32 77 50 50, emilielenoble.docteur@gmail.com
Emile Lenoble, Dr
Pont de L'Arche
Pont-de-l'Arche, 27340
Julien Boudier, Dr, 02 35 23 02 28, julien.boudier1@univ-rouen.fr
Julien Boudier, Dr
Romilly Sur Andelle
Romilly-sur-Andelle, 27610
Emmanuel Hazard, Dr, 02 32 49 77 29, dr.e.hazard@orange.fr
Emmanuel Hazard, Dr
About this study
Official title: Identifying and Managing Frailty in the Elderly in a Multiprofessional Health Home
"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.
Read the 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.
- Conditions
- Elderly, Frail
- Being tested
- Quality of life test
- Keywords
- identifying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of life testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Quality of life test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (11)
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
Measured: 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
Measured: 2 years
Drug intake at M6, M12 and M24
Number of medications taken at M6, M12 and M24
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 2 years
Patient nutritional status at M6, M12 and M24
Nutritional status, measured by MNA test score at M0, M6, M12 and M24
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Jun 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly, FrailStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Lucille PELLERIN, Dr, Study chair, Rouen University Department of General Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560723
- Sponsor's protocol ID
- 2022/0348/HP
- Other IDs
- 2023-A02358-37
- Acronym
- FRAPA
- Status last verified
- Jun 2026
- First submitted
- 18 Jul 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Managing Frailty in the Elderly in a Multiprofessional Health Home
- ClinicalTrials.gov ID
- NCT06560723
- Acronym / sponsor ID
- FRAPA / 2022/0348/HP
- Conditions
- Elderly, Frail
- Keywords
- identifying
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Group 1 Interventional Arm (with PHP) | Other | Diagnostic Test: Quality of life testThe 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. |
| Group 2 Control Arm (without PHP) | Other | Diagnostic Test: Quality of life testIn 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. |
Who may qualify
- Ages
- 70 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quality of life testThe 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. | Diagnostic test | Group 1 Interventional Arm (with PHP), Group 2 Control Arm (without PHP) |
Primary outcome
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
11 secondary outcomes
Patient quality of life at M6 and M12
Time frame: 1 year
Emergency room visits and hospitalizations at M6, M12 and M24
Time frame: 2 years
Drug intake at M6, M12 and M24
Time frame: 2 years
Therapeutic compliance at M6, M12 and M24
Time frame: 2 years
Patient autonomy at M6, M12 and M24.
Time frame: 2 years
Falls and patient mobility at M6, M12 and M24
Time frame: 2 years
Patient nutritional status at M6, M12 and M24
Time frame: 2 years
Patient's cognitive status at M6, M12 and M24
Time frame: 2 years
Patient's emotional state at M6, M12 and M24
Time frame: 2 years
Patient's social fragility at M6, M12 and M24
Time frame: 2 years
Patient autonomy at M6, M12 and M24.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lucille PELLERIN, Dr study chair
Rouen University Department of General Medicine
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quality of life test in people with Elderly, Frail, run by University Hospital, Rouen at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Blandine B BILLET, Dr (06 38 12 80 25 ext. +33, blandine.billet@wanadoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of implementing a personalized healthcare plan (PPS) on patient quality of life at M24 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.