Heart FailureSELENENCT04022122
Impact of Socio Economic Limitations on Health Outcomes in Patients With Recent Admission for Heart Failure
An observational study of Heart Failure, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
To assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for crhonic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of CHF patients and to study the associations between… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- Type of treatment
- Surgery or procedure
- How many people
- 121 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jul 2019to 1 Jan 2023
- How long will I take part?
- 6 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: It will include, consecutively, all patients with a HF hospitalization within 30 days, discharged alive, and whose main diagnosis at discharge is HF.
Who may be able to join
- Age ≥ 18 years old.
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
- Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent must be obtained before any assessment is performed.
- Patients receiving oral standard medication for chronic heart failure (CHF).
- All patients will be eligible regardless the level of left ventricular ejection fraction (LVEF).
Who cannot join
- Age<18 years old.
- Death before hospital discharge.
- The patient is unable or unwilling to give the informed consent to participate.
- Unstable patients with signs of fluid overload or low cardiac output.
Trial locations and contacts
1 site in 1 country.
Spain1 site
University Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
About this study
Official title: Impact of Socio Economic Limitations on hEalth Outcomes in Patients With Complex and Advanced Chronic Cardiovascular Conditions in High-standard iNtegrated Care Environements (SELENE Study)
To assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for crhonic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of CHF patients and to study the associations between socio-economic level and other psychosocial aspects (secondary objective).
Read the detailed description
The SELENE Study (Impact of SocioEconomic Limitations on health outcomes in patients with complex and advanced chronic cardiovascular conditions in high-standard iNtegrated care Environments) is an observational, cohort, prospective, multicenter study of consecutive patients treated in a comprehensive heart failure (HF) management program, and hospitalized by decompensated HF in our healthcare area; aimed at evaluating the impact of socioeconomic level on the effectiveness of a comprehensive multidisciplinary program of transitional care to patients with HF, both globally and in the various profiles of chronic management of HF.
In this study we aim to assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for chronic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of HF patients and to study the associations between NSE and other psychosocial aspects (secondary objective).
All patients will have a detailed assessment by a social worker of a battery of psychosocial and functional variables, including educational level, functional status, cognitive status, family support, or the existence of a primary caregiver and an assessment of purchasing power through the value of monthly income. The events that will be analyzed, both for the primary objective of the study and the secondary objective related to the different follow-up profiles, will be re-admissions at 30 days (primary event), and mortality at 30, 90 and 180 days, as well as hospital admission at 90 days and 6 months (secondary events). Using the "median" income group as a reference, comparisons will be made between the rates of these events among the different groups.
The researchers hypothesize that the socioeconomic level has an impact on clinical events of HF patients so that the effectiveness of comprehensive care programs for HF is attenuated in patients with low socioeconomic level.
- Conditions
- Heart Failure
- Being tested
- Usual Care follow-up in a heart failure program.
- Keywords
- Socioeconomic Level, Disease Management, Chronic Care Model, Transitional Care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual Care follow-up in a heart failure program.Procedure or surgery
Standard follow-up involves hospital and primary care for HF patients. In this context, physicians and nurses experienced in the care and management of HF direct care. HF care is based on 1) active detection of newly admitted HF patients, 2) planned educational interventions to improve self-care, 3) completion of a comprehensive psychosocial assessment of patients and caregivers, 4) discharge planning and home transition coordination involving the hospital HF team and Primary Care teams, 5) structured and planned evidence-based follow-up shortly after discharge from hospital.
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure patients | The study does not imply any specific therapeutic intervention, and will not imply any change in the management of the participating patients, who will follow the usual clinical controls and will receive the medical and invasive treatments usually provided to patients with HF in our health area; as well as the different modalities of specific health education for this disease. At the time of hospital discharge, patients will be handled according to the usual protocols of the center established for outpatient follow-up of HF patients. Receives: Procedure: Usual Care follow-up in a heart failure program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of cardiovascular death or non-fatal heart failure events
Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission.
Measured: Six months after inclusion of the patient.
Secondary outcomes (8)
Readmission (all-cause, HF and cardiovascular) rate and total number.
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Days in hospital (all-cause, HF and cardiovascular).
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Rate of emergency visits.
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Rate of non-fatal HF events.
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Mortality for any cause and cardiovascular mortality.
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Change of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Change of quality of life using a validated questionnaire (EUROQOL - 5D).
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Patient satisfaction using a Likert-type scale.
Comparison of the different socioeconomic levels at the end of follow-up.
Measured: Six months after inclusion of the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start15 Jul 2019
- Primary completion1 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies 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
- Prospective
- Enrolment
- 121 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Responsible party
- Principal investigator, Josep Comín, Hospital Universitari de Bellvitge
- Investigators
- Josep Comín Colet, MD,PhD, Principal investigator, Head of the Cardiology Department and the Community Heart Failure Unit. MD, PhD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022122
- Sponsor's protocol ID
- IDIBELL-2019/PR157/19
- Acronym
- SELENE
- Status last verified
- Oct 2023
- First submitted
- 14 Jul 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Socio Economic Limitations on hEalth Outcomes in Patients With Complex and Advanced Chronic Cardiovascular Conditions in High-standard iNtegrated Care Environements (SELENE Study)
- ClinicalTrials.gov ID
- NCT04022122
- Acronym / sponsor ID
- SELENE / IDIBELL-2019/PR157/19
- Conditions
- Heart Failure
- Keywords
- Socioeconomic Level, Disease Management, Chronic Care Model, Transitional Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Institut d'Investigació Biomèdica de Bellvitge
- Study start
- 15 Jul 2019 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 16 Jul 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.
To assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for crhonic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of CHF patients and to study the associations between socio-economic level and other psychosocial aspects (secondary objective).
Detailed description
The SELENE Study (Impact of SocioEconomic Limitations on health outcomes in patients with complex and advanced chronic cardiovascular conditions in high-standard iNtegrated care Environments) is an observational, cohort, prospective, multicenter study of consecutive patients treated in a comprehensive heart failure (HF) management program, and hospitalized by decompensated HF in our healthcare area; aimed at evaluating the impact of socioeconomic level on the effectiveness of a comprehensive multidisciplinary program of transitional care to patients with HF, both globally and in the various profiles of chronic management of HF.
In this study we aim to assess the impact of the socio-economic level on the effectiveness of a comprehensive multidisciplinary program of transitional care for chronic heart failure patients (primary objective); to analyze this specifically in the various chronic management profiles of HF patients and to study the associations between NSE and other psychosocial aspects (secondary objective).
All patients will have a detailed assessment by a social worker of a battery of psychosocial and functional variables, including educational level, functional status, cognitive status, family support, or the existence of a primary caregiver and an assessment of purchasing power through the value of monthly income. The events that will be analyzed, both for the primary objective of the study and the secondary objective related to the different follow-up profiles, will be re-admissions at 30 days (primary event), and mortality at 30, 90 and 180 days, as well as hospital admission at 90 days and 6 months (secondary events). Using the "median" income group as a reference, comparisons will be made between the rates of these events among the different groups.
The researchers hypothesize that the socioeconomic level has an impact on clinical events of HF patients so that the effectiveness of comprehensive care programs for HF is attenuated in patients with low socioeconomic level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure patients | – | Procedure: Usual Care follow-up in a heart failure program.The study does not imply any specific therapeutic intervention, and will not imply any change in the management of the participating patients, who will follow the usual clinical controls and will receive the medical and invasive treatments usually provided to patients with HF in our health area; as well as the different modalities of specific health education for this disease. At the time of hospital discharge, patients will be handled according to the usual protocols of the center established for outpatient follow-up of HF patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- It will include, consecutively, all patients with a HF hospitalization within 30 days, discharged alive, and whose main diagnosis at discharge is HF.
Key inclusion criteria (6 listed)
- Age ≥ 18 years old.
- Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study or in the process of discharge planning.
- Heart Failure diagnosis according to European Society of Cardiology (ESC) criteria.
- Written informed consent must be obtained before any assessment is performed.
- Patients receiving oral standard medication for chronic heart failure (CHF).
Key exclusion criteria (4 listed)
- Age<18 years old.
- Death before hospital discharge.
- The patient is unable or unwilling to give the informed consent to participate.
- Unstable patients with signs of fluid overload or low cardiac output.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual Care follow-up in a heart failure program.Standard follow-up involves hospital and primary care for HF patients. In this context, physicians and nurses experienced in the care and management of HF direct care. HF care is based on 1) active detection of newly admitted HF patients, 2) planned educational interventions to improve self-care, 3) completion of a comprehensive psychosocial assessment of patients and caregivers, 4) discharge planning and home transition coordination involving the hospital HF team and Primary Care teams, 5) structured and planned evidence-based follow-up shortly after discharge from hospital. | Procedure or surgery | Heart Failure patients |
Primary outcome
Occurrence of cardiovascular death or non-fatal heart failure events
Time frame: Six months after inclusion of the patient.
Occurrence of cardiovascular death or non-fatal heart failure events (time to first event) during a follow-up period of 6 months. Non-fatal heart failure event is defined as a new episode of worsening of symptoms and signs consistent with acute decompensated HF requiring intravenous decongestive therapy (e.g. diuretics) either on an outpatient basis (day-case HF hospital) or in the emergency department (<24 hours) or requiring unplanned hospital admission (>24 hours) or complicating the course of a non-cardiovascular admission.
8 secondary outcomes
Readmission (all-cause, HF and cardiovascular) rate and total number.
Time frame: Six months after inclusion of the patient.
Days in hospital (all-cause, HF and cardiovascular).
Time frame: Six months after inclusion of the patient.
Rate of emergency visits.
Time frame: Six months after inclusion of the patient.
Rate of non-fatal HF events.
Time frame: Six months after inclusion of the patient.
Mortality for any cause and cardiovascular mortality.
Time frame: Six months after inclusion of the patient.
Change of self-care using a validated scale (European Heart Failure Self-Care Behavior Scale)
Time frame: Six months after inclusion of the patient.
Change of quality of life using a validated questionnaire (EUROQOL - 5D).
Time frame: Six months after inclusion of the patient.
Patient satisfaction using a Likert-type scale.
Time frame: Six months after inclusion of the patient.
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 10 Oct 2023.
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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.
Josep Comín Colet, MD,PhD principal investigator
Head of the Cardiology Department and the Community Heart Failure Unit. MD, PhD
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 Heart Failure, run by Hospital Universitari de Bellvitge at 1 site in Spain.
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 6 inclusion and 4 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 10 Oct 2023. 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 Spain. 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?
Occurrence of cardiovascular death or non-fatal heart failure events (time frame: Six months after inclusion of the patient.). 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 10 Oct 2023.