NCT03992040

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
677

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

July 25, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 26, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

June 18, 2019

Last Update Submit

April 24, 2024

Conditions

Keywords

Regional Public Health authorities (ARS) scoreReinforced Home Nursing Care Services (SSIADR)

Outcome Measures

Primary Outcomes (1)

  • Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.

    Assess the hospitalization frequency for patients with an enhanced SSIAD placement compared to similar patients in conventional SSIAD.

    12 months

Secondary Outcomes (8)

  • Assessment of commorbidity risk according Charlson score

    12 months

  • Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale

    12 months

  • Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

    12 months

  • Assessment of teh degree of autonomy according AGGIR score

    12 months

  • Assessment of quality of life according "Nottingham health profile" scale

    12 months

  • +3 more secondary outcomes

Study Arms (2)

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

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.

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SSIAD SAPA, 139 Boulevard Saint-Denis

Courbevoie, Île-de-France Region, 92400, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2019

First Posted

June 19, 2019

Study Start

July 25, 2019

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

April 26, 2024

Record last verified: 2024-04

Locations