Frailty Heart Failure Study

Jewish General Hospital

Status

Unknown

Conditions

Heart Failure

Frail Elderly Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT03887351

MP-05-2019-1682

Details and patient eligibility

About

A prospective longitudinal cohort study aimed at measuring frailty and its associated risk factors community dwelling older adults aged 65 years or older.

The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities.

The primary outcome is all-cause mortality at 1-year post enrollment.

Full description

The overarching research question is as follows: Is frailty predictive of patient-centered outcomes in older adults with heart failure (HF)? Hypotheses regarding this research question are: 1) Frailty is associated with increased 12-month mortality, 2) Frailty is associated with increased 3-month mortality or unplanned hospitalization, 3) Frailty is associated with lower baseline health-related quality of life (HrQOL), and 4) Frailty is associated with worsening HrQOL at 3 months.

There are three specific study objectives. 1) To compare the ability of various frailty measures to predict all-cause mortality, hospitalizations, and HrQOL in patients attending an outpatient HF clinic. 2) To examine the determinants of longitudinal changes in frailty measures over time. Lastly, 3) To examine the clinical and frailty related determinants of fatigue in older adults

A prospective longitudinal cohort study will be conducted at a specialized heart failure (HF) clinic at the Jewish General Hospital (JGH) and Royal Victoria Hospital (RVH). The study aims to measure frailty and its associated risk factors in community dwelling individuals, aged 65 years or older and who have been diagnosed with HF (preserved or reduced ejection fraction) for at least 3 months. The multi-domain geriatric assessment will include questionnaires administered by interview, physical performance tests, body composition analysis using a bioimpedance machine, review of clinically acquired biochemical and imaging tests, and chart review. The geriatric domains evaluated will include: frailty status, hearing impairment, visual impairment, polypharmacy, sarcopenia, malnutrition, cognitive impairment, depression, fatigue, sleep difficulties, and disabilities. Baseline assessment will approximate to 40 minutes of patient contact time while follow up phone interviews at 3 and 12 months will approximate to 20 minutes. Outcome measures such as all-cause mortality, HrQOL, unplanned hospitalization will be assessed at 3 months and 1-year post enrollment.

Enrollment

280 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Community dwelling outpatients
Aged 65 years or older
A HF diagnosis with preserved or reduced ejection fraction for at least 3 months
Agreed to participate and signed an informed consent form

Exclusion criteria

Outpatients with a recent hospital admission within 3 months
Acutely decompensated HF status at the time of their visit
Received intravenous (IV) diuretics or IV inotropes within 3 months
A moribund health status with life expectancy less than 3 months
Scheduled to undergo a major surgical or percutaneous procedure within 3 months
Implantation of cardiac resynchronization therapy within the past 3 months or intent to place
Patients with a history of heart transplant, currently on the transplant list or with an left ventricular device
Severe neuropsychiatric impairments
Non -English or French speaking