Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD) Device (SSIADR)

April 24, 2024 updated by: Gérond'if

Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
677

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Ile-de-France
      • Courbevoie, Ile-de-France, France, 92400
        • SSIAD SAPA, 139 Boulevard Saint-Denis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD.
Time Frame: 12 months
Assess the hospitalization frequency for patients with an enhanced SSIAD placement compared to similar patients in conventional SSIAD.
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time Frame: 12 months
12 months
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time Frame: 12 months
12 months
Assessment of commorbidity risk according Charlson score
Time Frame: 12 months
12 months
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time Frame: 12 months
12 months
Assessment of teh degree of autonomy according AGGIR score
Time Frame: 12 months
12 months
Assessment of quality of life according "Nottingham health profile" scale
Time Frame: 12 months
12 months
Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Time Frame: 12 months
12 months
Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gérond'if

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 18, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-A01188-49

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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