Intervention by a Cardiologist and Geriatrician in Elderly Patients After Admission Due to Heart Failure.

Heart Failure Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555318
• Other study ID #: 2017/7653/I
• Status: Completed
• Phase: N/A
• Start date: June 14, 2018
• Est. completion date: November 5, 2020

Study information

• Verified date: November 2019
• Source: Parc de Salut Mar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Patients older than 75 years with a recent admission for heart failure (within the previous 10 days).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Ambulatory visit
All patients will have an ambulatory visit with the cardiologist.
• Combined ambulatory visit
Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.
• Geriatric intervention
After the geriatric assessment, measures to improve frailty will be started.

Locations

Country	Name	City	State
Spain	Hospital del Mar, Parc de Salut Mar	Barcelona	Non-USA

Sponsors (2)

Lead Sponsor	Collaborator
Parc de Salut Mar	Fundacion MAPFRE

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	Number of participants with heart failure hospitalization within the defined time points	Number of participants with heart failure hospitalization at 1 year follow-up	1 year
Secondary	Number of participants dead within the defined time points	Number of participants dead at 1 year follow-up	1 year
Secondary	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.	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year