Heart FailureNCT03555318
Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.
A study testing Ambulatory visit, Combined ambulatory visit and Geriatric intervention in people with Heart Failure, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ambulatory visit, Combined ambulatory visit and Geriatric intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 14 Jun 2018to 5 Nov 2020
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).
Who cannot join
- Patients in palliative care.
- Patients with chronic pathologies with expected life expectancy <1 year.
- Patients discharged to a skilled nursing facility
- Patients with heart valve replacement during index admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.
Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.
Read the detailed description
Patients will be invited to participate on the day of hospital discharge. Once the informed consent has been signed, patients will be randomized with a 1: 1 ratio to conventional follow-up (cardiologist) or combined follow-up (ambulatory visit with cardiologist and geriatrics on the same day). Randomization will be stratified according to the presence or absence of criteria of frailty and ventricular function (cut-off 50%) to ensure that both groups are balanced. This stratification will be achieved by generating 4 different randomization lists. Frailty will be assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale. Randomization will be carried out by administrative staff independent of the study following a computer generated randomization scheme.The first visit will be made in less than 10 days after discharge from the hospital. Lawton and Barthel index and Pfeiffer test and quality of life test will be done in both groups.
The cost associated with care in the hospital is collected in each patient and therefore the total cost of the admissions, ambulatory visits and emergencies of each patient will be retrospectively evaluated.
In patients in the intervention arm the following areas will be evaluated: social sphere (Social and family evaluation scale of Gijón (abbreviated and modified) (Barcelona version), functional capacity (Barthel index and Lawton index), cognitive sphere (Pfeiffer test), emotional sphere (Geriatric Depression Scale Yesavage), nutritional status (Mini-Nutritional Assessment Short Form, plasma albumin), comorbidity (Charlson index) and the presence of geriatric syndromes (falls, polypharmacy, ulcers pressure, constipation, incontinence, insomnia.) Interdisciplinary interventions will be carried out in each of the areas evaluated.
Follow-up will be carried out at the heart failure clinic of the Cardiology Department at 3, 6 and 12 months. A clinical event evaluation committee will be appointed, consisting of 2 independent cardiologists, who will blindly adjudicate the events that occurred during the duration of the study.
- Conditions
- Heart Failure
- Being tested
- Ambulatory visit, Combined ambulatory visit, Geriatric intervention
- Keywords
- Heart failure, Frailty, Outcome, Hospitalization, Mortality
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory visitOther
All patients will have an ambulatory visit with the cardiologist.
Combined ambulatory visitOther
Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.
Geriatric interventionOther
After the geriatric assessment, measures to improve frailty will be started.
| Study group | Role | What they receive |
|---|---|---|
| Geriatrician + Cardiologist | Experimental | Patients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician. Receives: Other: Combined ambulatory visit; Other: Geriatric intervention |
| Cardiologist | Active comparator | Patients randomized to usual care (ambulatory follow up with a cardiologist). Receives: Other: Ambulatory visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with all-cause hospitalization within the defined time points
Number of participants with an all-cause hospitalization at 1 year follow-up
Measured: 1 year
Secondary outcomes (6)
Number of participants with heart failure hospitalization within the defined time points
Number of participants with heart failure hospitalization at 1 year follow-up
Measured: 1 year
Number of participants dead within the defined time points
Number of participants dead at 1 year follow-up
Measured: 1 year
Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a self-applicable health related quality of life instrument specific to heart failure, within the defined time points. The KCCQ ranges from 0 to 100, with 100 being the best state. A change in 5 points at 1 year follow-up will be considered clinically relevant.
Measured: 1 year
Change in functional capacity measured with the Barthel index within the defined time points
Change in functional capacity measured with the Barthel index at 1 year follow-up
Measured: 1 year
Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
Change in the number of participants with more than 5 medications (polypharmacy) at 1 year follow-up
Measured: 1 year
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) at 1 year follow-up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study start14 Jun 2018
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacion MAPFRE
- Responsible party
- Sponsor
- Investigators
- Nuria Farre, MD, Principal investigator, Institut Hospital del Mar d'Investigacions Mèdiques
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555318
- Sponsor's protocol ID
- 2017/7653/I
- Status last verified
- Nov 2019
- First submitted
- 7 May 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Luiso D, Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Belarte-Tornero LC, Valdivielso-More S, Morales RO, Vazquez O, Farre N. Quality of Life in Older Patients after a Heart Failure Hospitalization: Results from the SENECOR Study. J Clin Med. 2022 May 27;11(11):3035. doi: 10.3390/jcm11113035.
PubMed 35683423Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Sole-Gonzalez E, Belarte-Tornero LC, Valdivielso-More S, Vazquez O, Farre N. Randomized Controlled Trial Comparing a Multidisciplinary Intervention by a Geriatrician and a Cardiologist to Usual Care after a Heart Failure Hospitalization in Older Patients: The SENECOR Study. J Clin Med. 2022 Mar 30;11(7):1932. doi: 10.3390/jcm11071932.
PubMed 35407540
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.
- ClinicalTrials.gov ID
- NCT03555318
- Acronym / sponsor ID
- 2017/7653/I
- Conditions
- Heart Failure
- Keywords
- Heart failure, Frailty, Outcome, Hospitalization, Mortality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Collaborators
- Fundacion MAPFRE
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 13 Jun 2018 (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.
Randomized clinical trial in which patients with a recent admission for heart failure in the cardiology department of the Hospital de Mar will be randomized to usual follow-up (cardiologist of the Heart Failure Unit) or follow-up by cardiologist and intervention by the geriatrician. This visit will be done at the same time. The main gial of this study is to evaluate whether the combined intervention of a cardiologist and a geriatrician reduces hospital all-cause rehospitalizations at 1 year.
Detailed description
Patients will be invited to participate on the day of hospital discharge. Once the informed consent has been signed, patients will be randomized with a 1: 1 ratio to conventional follow-up (cardiologist) or combined follow-up (ambulatory visit with cardiologist and geriatrics on the same day). Randomization will be stratified according to the presence or absence of criteria of frailty and ventricular function (cut-off 50%) to ensure that both groups are balanced. This stratification will be achieved by generating 4 different randomization lists. Frailty will be assessed using the Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale. Randomization will be carried out by administrative staff independent of the study following a computer generated randomization scheme.The first visit will be made in less than 10 days after discharge from the hospital. Lawton and Barthel index and Pfeiffer test and quality of life test will be done in both groups.
The cost associated with care in the hospital is collected in each patient and therefore the total cost of the admissions, ambulatory visits and emergencies of each patient will be retrospectively evaluated.
In patients in the intervention arm the following areas will be evaluated: social sphere (Social and family evaluation scale of Gijón (abbreviated and modified) (Barcelona version), functional capacity (Barthel index and Lawton index), cognitive sphere (Pfeiffer test), emotional sphere (Geriatric Depression Scale Yesavage), nutritional status (Mini-Nutritional Assessment Short Form, plasma albumin), comorbidity (Charlson index) and the presence of geriatric syndromes (falls, polypharmacy, ulcers pressure, constipation, incontinence, insomnia.) Interdisciplinary interventions will be carried out in each of the areas evaluated.
Follow-up will be carried out at the heart failure clinic of the Cardiology Department at 3, 6 and 12 months. A clinical event evaluation committee will be appointed, consisting of 2 independent cardiologists, who will blindly adjudicate the events that occurred during the duration of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Geriatrician + Cardiologist | Experimental | Other: Combined ambulatory visit, Other: Geriatric interventionPatients randomized to a combined ambulatory follow up with a cardiologist and a geriatrician. |
| Cardiologist | Active comparator | Other: Ambulatory visitPatients randomized to usual care (ambulatory follow up with a cardiologist). |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).
Key exclusion criteria (4 listed)
- Patients in palliative care.
- Patients with chronic pathologies with expected life expectancy <1 year.
- Patients discharged to a skilled nursing facility
- Patients with heart valve replacement during index admission
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 |
|---|---|---|
| Ambulatory visitAll patients will have an ambulatory visit with the cardiologist. | Other | Cardiologist |
| Combined ambulatory visitBoth the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists. | Other | Geriatrician + Cardiologist |
| Geriatric interventionAfter the geriatric assessment, measures to improve frailty will be started. | Other | Geriatrician + Cardiologist |
Primary outcome
Number of participants with all-cause hospitalization within the defined time points
Time frame: 1 year
Number of participants with an all-cause hospitalization at 1 year follow-up
6 secondary outcomes
Number of participants with heart failure hospitalization within the defined time points
Time frame: 1 year
Number of participants dead within the defined time points
Time frame: 1 year
Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points
Time frame: 1 year
Change in functional capacity measured with the Barthel index within the defined time points
Time frame: 1 year
Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points
Time frame: 1 year
Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points
Time frame: 1 year
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 6 Nov 2020.
- Derived from this study: PubMed 35683423Luiso D, Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Belarte-Tornero LC, Valdivielso-More S, Morales RO, Vazquez O, Farre N. Quality of Life in Older Patients after a Heart Failure Hospitalization: Results from the SENECOR Study. J Clin Med. 2022 May 27;11(11):3035. doi: 10.3390/jcm11113035.
- Derived from this study: PubMed 35407540Herrero-Torrus M, Badosa N, Roqueta C, Ruiz-Bustillo S, Sole-Gonzalez E, Belarte-Tornero LC, Valdivielso-More S, Vazquez O, Farre N. Randomized Controlled Trial Comparing a Multidisciplinary Intervention by a Geriatrician and a Cardiologist to Usual Care after a Heart Failure Hospitalization in Older Patients: The SENECOR Study. J Clin Med. 2022 Mar 30;11(7):1932. doi: 10.3390/jcm11071932.
- Individual participant dataSharing planned: No
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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.
Nuria Farre, MD principal investigator
Institut Hospital del Mar d'Investigacions Mèdiques
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory visit, Combined ambulatory visit and Geriatric intervention in people with Heart Failure, run by Parc de Salut Mar 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 1 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 6 Nov 2020. 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?
Number of participants with all-cause hospitalization within the defined time points (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03555318, which also lists 2 linked publications.
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 6 Nov 2020.