NCT03089034

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 24, 2017

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

8.3 years

First QC Date

March 20, 2017

Last Update Submit

February 3, 2025

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (7)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (4)

  • 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 )

  • 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)

  • 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)

  • Caregiver's perception of patient's end-of-life care assessed after patient's death

    8 weeks bereavement

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, Singapore, 169609, Singapore

Location

Related Publications (2)

  • 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.

    PMID: 39545423DERIVED

  • 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.

    PMID: 30224389DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 24, 2017

Study Start

July 24, 2017

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)