Singapore Cohort of Patients with Advanced Heart Failure

Active, not recruiting

• Conditions: Chronic Heart Failure

• Registration Number: NCT03089034
• Lead Sponsor: Duke-NUS Graduate Medical School

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.

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-24
• Study Start: 2017-07-24
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in activities of daily living among patients through the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess limitations in activities of daily living of patients through OARS Multidimensional Functional Assessment Questionnaire
Change in distress among patients through the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess patients' distress through the distress thermometer
Change in patients' cognitive status	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess patients' cognitive status through Montreal Cognitive Assessment
Change in patient's compliance with treatment regimens and self-care behaviours	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months,24 months)	Investigators will describe patients' compliance with their self-care behaviour using the Self Care of Heart Failure Index (SCHFI)
Total health care expenditure during the last year of life through analysis of medical bills	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investogators will calculate total health care expenditure during the last year of patient's life as the sum total of expenditures incurred at clinics etc
Change in overall quality of life among patients through the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess patient's quality of life through FACT-G Time frame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months)
Change in patient's perceived quality of care during the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will describe patients' assessment of their own care using a scale used by Ayanian et al (JCO, 2010) that consists of 13 questions.

Secondary Outcome Measures

Name	Time	Method
Change in patient's awareness of hospice palliative care services among heart failure patients	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months )	Investigators will assess change in patients' awareness of hospice palliative care services by asking them if they are aware and are using hospice palliative care services.
Change in caregiver's level of emotional distress through the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).
Change in caregiver burden through the last year of life	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)	Investigators will assess caregiver burden through modified Caregiver Reaction Assessment Scale Instrument
Caregiver's perception of patient's end-of-life care assessed after patient's death	8 weeks bereavement	Investigators will assess caregiver perceived quality of end-of-life care through CEQUEL.

Trial Locations

Locations (1)

National Heart Centre Singapore; 🇸🇬 Singapore, Singapore