Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03992040 |
| Other study ID # |
2019-A01188-49 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 25, 2019 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Gérond'if |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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).
