Singapore Cohort of Patients with Advanced Heart Failure

NCT ID: NCT03089034

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-24

Study Completion Date

2025-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

Exclusion Criteria

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


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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role collaborator

National Heart Centre Singapore

OTHER

Sponsor Role collaborator

Duke-NUS Graduate Medical School

OTHER

Sponsor Role lead

Responsible Party

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Eric A. Finkelstein

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Heart Centre Singapore

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

References

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Lee JJ, Malhotra C, Sim KLD, Yeo KK, Finkelstein E, Ozdemir S. A Longitudinal Study of the Association of Awareness of Disease Incurability with Patient-Reported Outcomes in Heart Failure. Med Decis Making. 2025 Jan;45(1):97-108. doi: 10.1177/0272989X241297694. Epub 2024 Nov 15.

Reference Type DERIVED
PMID: 39545423 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30224389 (View on PubMed)

Other Identifiers

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2016/3046

Identifier Type: -

Identifier Source: org_study_id

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