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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70-100
SponsorUniversity Hospital, Rouen

About this trial

"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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Group 1 Interventional Arm (with PHP)Other 1 intervention
Group B: Group 2 Control Arm (without PHP)Other 1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

1

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

Time frame
1 year
2

Emergency room visits and hospitalizations at M6, M12 and M24

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

Time frame
2 years
3

Drug intake at M6, M12 and M24

Number of medications taken at M6, M12 and M24

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

1

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.

Time frame
2 years

Sponsors and contacts

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University Hospital, Rouen

Lead sponsor

Ministry of Health, France

Collaborator

This trial is not recruiting at the moment. You can still explore other options: