Clinical trial NCT03992040: Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD) Device
Official title: Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical Prescription
Keywords: Regional Public Health authorities (ARS) score
Reinforced Home Nursing Care Services (SSIADR)
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 677
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population for this study is elderly, polypathological patients who have been prescribed SSIAD. Patients eligible to participate in Reinforced SSIAD experiment are those who meet inclusion and non-inclusion criteria listed below. Patient selection will be done in the SSIAD themselves.

Brief summary: The main purpose is to study, in comparison to classic Home Nursing Care Services (SSIAD), the effect of reinforced Home Nursing Care Services (SSIAD) on the occurrence of hospitalizations

Detailed description: It's a non-interventional, multi-centred, controlled study.

Inclusions will start with patients benefit from a so-called "reinforced" bed in the experimental Home Nursing Care Services (SSIAD), that is, with a score between 11 and 21 on the regional public health authorities (ARS) score. Patients from the classic Home Nursing Care Services SSIAD (control arm) will be inclused on a matching mode to the individual clinical profiles of patients recruited into the reinforced Home Nursing Care Services (SSIAD). Matching will be based on age, sex, and comorbidity score (Charlson scale). Screening for matching will be done by a geriatric physician appointed by the sponsor. Once screened in, patients will be proposed the study by the Home Nursing Care Services SSIAD lead investigator who provides home care. Patients in the control arm will also express no opposition. For each patient accepting the study, their family caregiver - if there is one - will also be proposed the study. Various data: Prescription medicinal, reason and duration of hospitalization, number and reason for emergency department presentations, independence and dependency scores and other scales will be collected retrospectively, at inlcusion (J0) , then monthly (M1 to M12).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 60 years old
* Having obtained a place in SSIAD by medical prescription
* Able to understand and respond to study questionnaires and evaluations with or without the Assistance of a third party
* Resident in territories of activities of the SSIAD participating in assessment
* With social coverage
* Having expressed non-oppostion to his participation in study and documented in his medical file
* Only for patients in " einforced SSIAD ": patient with a so-called "reinforced" bed financed by " Regional Public Health authorities " (ARS) of Ile-de-France, and with a score between 11 and 21 on the ARS score

Exclusion Criteria:

* Age \< 60 years old
* Expressing his opposition to participate in the study
* Not resident in the territory of activity of SSIAD
* Requires only technical care and management in the act
* Unable to understand and respond to study questionnaires and evaluations, even with third party assistance

Primary outcomes:
measure: Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of commorbidity risk according Charlson score
timeFrame: 12 months
measure: Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
timeFrame: 12 months
measure: Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
timeFrame: 12 months
measure: Assessment of teh degree of autonomy according AGGIR score
timeFrame: 12 months
measure: Assessment of quality of life according "Nottingham health profile" scale
timeFrame: 12 months
measure: Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
timeFrame: 12 months
measure: Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
timeFrame: 12 months
measure: Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Courbevoie
country: France
facility: SSIAD SAPA, 139 Boulevard Saint-Denis
state: Ile-de-France
Study officials:
References: