Singapore Cohort of Patients With Advanced Heart Failure

Chronic Heart Failure Clinical Trial

— SCOPAH  

Official title:

Singapore Cohort of Patients With Advanced Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03089034
• Other study ID #: 2016/3046
• Status: Active, not recruiting
• Start date: July 24, 2017
• Est. completion date: October 31, 2025

Study information

• Verified date: October 2023
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Locations

Country	Name	City	State
Singapore	National Heart Centre Singapore	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	National Heart Centre Singapore, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in overall quality of life among patients through the last year of life	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)	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Primary	Change in distress among patients through the last year of life	Investigators will assess patients' distress through the distress thermometer	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Primary	Change in activities of daily living among patients through the last year of life	Investigators will assess limitations in activities of daily living of patients through OARS Multidimensional Functional Assessment Questionnaire	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Primary	Change in patient's perceived quality of care during the last year of life	Investigators will describe patients' assessment of their own care using a scale used by Ayanian et al (JCO, 2010) that consists of 13 questions.	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Primary	Change in patient's compliance with treatment regimens and self-care behaviours	Investigators will describe patients' compliance with their self-care behaviour using the Self Care of Heart Failure Index (SCHFI)	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months,24 months)
Primary	Total health care expenditure during the last year of life through analysis of medical bills	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	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Primary	Change in patients' cognitive status	Investigators will assess patients' cognitive status through Montreal Cognitive Assessment	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Secondary	Change in patient's awareness of hospice palliative care services among heart failure patients	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.	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months )
Secondary	Change in caregiver burden through the last year of life	Investigators will assess caregiver burden through modified Caregiver Reaction Assessment Scale Instrument	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Secondary	Change in caregiver's level of emotional distress through the last year of life	Investigators will assess caregiver's anxiety and depression through the Hospital Anxiety and Depression Scale (HADS).	From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
Secondary	Caregiver's perception of patient's end-of-life care assessed after patient's death	Investigators will assess caregiver perceived quality of end-of-life care through CEQUEL.	8 weeks bereavement