Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD) Device (SSIADR)
Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device
Study Overview
Status
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ile-de-France
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Courbevoie, Ile-de-France, France, 92400
- SSIAD SAPA, 139 Boulevard Saint-Denis
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Reinforced SSIAD (SSIADR arm )
Reinforced Home Nursing Care Services: Patients with a score between 11 and 21 on the regional public health authorities (ARS) score. This arm will benefit from better coordination and delivery of care, which can reduce hospitalizations and visits to emergency departments |
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Classic SSIAD (Control arm)
Classic Home Nursing Care Services.
For this arm, no direct benefit is expected since taking care, even for the heaviest patients, corresponds to current practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.
Time Frame: 12 months
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Assess the hospitalization frequency for patients with an enhanced SSIAD placement compared to similar patients in conventional SSIAD.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame: 12 months
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12 months
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Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time Frame: 12 months
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12 months
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Assessment of commorbidity risk according Charlson score
Time Frame: 12 months
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12 months
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Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame: 12 months
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12 months
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Assessment of teh degree of autonomy according AGGIR score
Time Frame: 12 months
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12 months
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Assessment of quality of life according "Nottingham health profile" scale
Time Frame: 12 months
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12 months
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Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Time Frame: 12 months
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12 months
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Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score
Time Frame: 12 months
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12 months
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2019-A01188-49
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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