Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical PrescriptionSSIADRNCT03992040
Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD) Device
An observational study of Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical Prescription, run by Gérond'if at 1 site in France.
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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical Prescription
- How many people
- 677 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2019to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
SSIAD SAPA, 139 Boulevard Saint-Denis
Courbevoie, Île-de-France Region, 92400
About this study
Official title: 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
Read the 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).
- Keywords
- Regional Public Health authorities (ARS) score, Reinforced Home Nursing Care Services (SSIADR)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
Assessment of commorbidity risk according Charlson score
Measured: 12 months
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Measured: 12 months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: 12 months
Assessment of teh degree of autonomy according AGGIR score
Measured: 12 months
Assessment of quality of life according "Nottingham health profile" scale
Measured: 12 months
Assessment of health-related quality of life according SF-36 (Medical outcome study Short-Form health survey-36 items)
Measured: 12 months
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Measured: 12 months
Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start25 Jul 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical PrescriptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 677 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992040
- Sponsor's protocol ID
- 2019-A01188-49
- Acronym
- SSIADR
- Status last verified
- Apr 2024
- First submitted
- 18 Jun 2019
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Medico-economic Relevance of Care of Polypathological Patients by a Reinforced Home Nursing Care Services (SSIAD)Device
- ClinicalTrials.gov ID
- NCT03992040
- Acronym / sponsor ID
- SSIADR / 2019-A01188-49
- Keywords
- Regional Public Health authorities (ARS) score, Reinforced Home Nursing Care Services (SSIADR)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 677 participants (actual)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 19 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
8 secondary outcomes
Assessment of commorbidity risk according Charlson score
Time frame: 12 months
Assessment of the degree of patient dependence according "Index of Independence in Activities of Daily Living" KATZ scale
Time frame: 12 months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 12 months
Assessment of teh degree of autonomy according AGGIR score
Time frame: 12 months
Assessment of quality of life according "Nottingham health profile" scale
Time frame: 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
Assessment of the emotional, physical and financial burden on a caregiver according Zarit burden scale
Time frame: 12 months
Assessment of qualityof life for caregiver according "36-Item Short Form Survey" (SF-36) Score
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polypathological Patient Having Obtained a Place in Home Nursing Care Services SSIAD by Medical Prescription, run by Gérond'if at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of hospitalization frequency for patients with Reinforced SSIAD compared to similar patients in classic SSIAD. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.