Clinical trial NCT03089034: Singapore Cohort of Patients with Advanced Heart Failure
Official title: Singapore Cohort of Patients with Advanced Heart Failure
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Heart Failure
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
name: National Heart Centre Singapore
First posted: 2017-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced chronic heart failure(New York Heart Association class III and IV), their primary informal caregivers and their treating physicians

Brief summary: Chronic Heart Failure (CHF) is one of the leading causes of death in Singapore. Although it is well established that CHF patients in Singapore are less likely to be referred to palliative care services than cancer patients, little data is available on end-of-life (EOL) experience of advanced CHF patients in Singapore, including the inter-relationships between patient decision-making, quality of life trajectories, and health and cost consequences.

Detailed description: To address this gap and to identify areas for better delivery of end-of-life services to patients with advanced CHF, the investigators propose to enrol a cohort of 300 patients with advanced CHF (New York Heart Association class III and IV), survey the participants every 4 months for a period of two years or till they die, whichever is earlier. The goal of this cohort study is to better understand the relationship between patient preferences, health care access, utilization, costs, and quality of life, and to identify strategies to improve the EOL experience for these patients. It is also important to recognize the significant role of the family in medical decision making in Asia. Previous studies from Singapore reveal that patients want their families to be involved in the decision making process. The role of the family in decision making is consistent with the Chinese culture of interdependency, obligations and filial piety. Decisions regarding treatment are often made by family caregivers, sometimes with little or no input from patients. Given this reality, the investigators will also enroll caregivers of the patients to evaluate their role in decision making for treatment of patients.

Eligibility criteria: Inclusion Criteria (patients):

* Age ≥ 21 years old
* Singaporean or Singapore Permanent Resident
* Diagnosis of advanced Congestive Heart Failure (New York Heart Association Class III and IV).
* Intact cognition (of patients ≥60 years of age) as determined by the Montreal Cognitive Assessment. If patient fails the cognitive test, he/she continues to be eligible for the study although self-reported data will no longer be collected. The primary informal caregiver of the patient will be approached for providing consent on behalf of the patient, to allow access to review of patient's medical and billing records

The inclusion criteria (primary informal caregivers)

* Age ≥ 21 years old
* Main person or one of the main providing care to the patient (e.g. accompanying patient for doctor's visits, helping the patient with day to day activities)
* Main person or one of the main ensuring provision of care (e.g. supervision of foreign domestic worker so that the patient is looked after)
* Main person or one of the main involved in making decisions regarding treatment the patient receives
* Patient they are caring for is enrolled in the study

The inclusion criteria (physicians) • Patients they are treating are enrolled in the study

Exclusion Criteria (patients):

* Patients who are not Singaporeans or Singapore Permanent Residents
* Patients who are ≤21 years of age
* Patients with psychiatric or cognitive disorders

Exclusion criteria (caregivers)

• Foreign domestic workers/ maids will be excluded from this study

Primary outcomes:
measure: Change in overall quality of life among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in distress among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in activities of daily living among patients through the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in patient's perceived quality of care during the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in patient's compliance with treatment regimens and self-care behaviours
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months,24 months)
measure: Total health care expenditure during the last year of life through analysis of medical bills
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in patients' cognitive status
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Secondary outcomes:
measure: Change in patient's awareness of hospice palliative care services among heart failure patients
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months )
measure: Change in caregiver burden through the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Change in caregiver's level of emotional distress through the last year of life
timeFrame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
measure: Caregiver's perception of patient's end-of-life care assessed after patient's death
timeFrame: 8 weeks bereavement
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
Study officials:
References:
citation: Malhotra C, Foo R, Singh R, Ozdemir S, Teo I, Sim D, Jaufeerally F, Aung T, Keong YK, Nadkarni N, Finkelstein EA. Study protocol for a cohort study of patients with advanced heart failure in Singapore. BMJ Open. 2018 Sep 17;8(9):e022248. doi: 10.1136/bmjopen-2018-022248.