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Completed

NCT Number: NCT03555318

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

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Frailty Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar, Parc de Salut Mar

Barcelona, Non-USA, 08003, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulatory visit

Other

All patients will have an ambulatory visit with the cardiologist.

Combined ambulatory visit

Other

Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.

Geriatric intervention

Other

After the geriatric assessment, measures to improve frailty will be started.

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of participants with heart failure hospitalization within the defined time points

    Time frame: 1 year

    Number of participants with heart failure hospitalization at 1 year follow-up

  2. Number of participants dead within the defined time points

    Time frame: 1 year

    Number of participants dead at 1 year follow-up

  3. Change in quality of life measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ) within the defined time points

    Time frame: 1 year

    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.

  4. Change in functional capacity measured with the Barthel index within the defined time points

    Time frame: 1 year

    Change in functional capacity measured with the Barthel index at 1 year follow-up

  5. Change in the number of participants with more than 5 medications (polypharmacy) within the defined time points

    Time frame: 1 year

    Change in the number of participants with more than 5 medications (polypharmacy) at 1 year follow-up

  6. Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) within the defined time points

    Time frame: 1 year

    Differences in total number of outpatient visits, emergency room visits and hospitalizations (resource use) at 1 year follow-up

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Collaborators

  • Fundacion MAPFRE

Registry information

Official study title

Randomized Clinical Trial: Assessment of a Multidisciplinary Intervention by a Cardiologist and Geriatrician After Hospital Admission Due to Heart Failure in Elderly Patients.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 13, 2018
Registry last updated
Nov 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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