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Chronic Heart FailureSCOPAHNCT03089034

Singapore Cohort of Patients with Advanced Heart Failure

An observational study of Chronic Heart Failure, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Chronic Heart Failure
How many people
300 participants
Where
1 siteSingapore
Study dates
24 Jul 2017to 31 Oct 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with advanced chronic heart failure(New York Heart Association class III and IV), their primary informal caregivers and their treating physicians

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National Heart Centre Singapore

    Singapore, Singapore, 169609

Other trials in Singapore

About this study

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.

Read the 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  2. Change in distress among patients through the last year of life

    Investigators will assess patients' distress through the distress thermometer

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  3. 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

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  4. 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.

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  5. 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)

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months,24 months)

  6. 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

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  7. Change in patients' cognitive status

    Investigators will assess patients' cognitive status through Montreal Cognitive Assessment

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

Secondary outcomes (4)

  1. 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.

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months )

  2. Change in caregiver burden through the last year of life

    Investigators will assess caregiver burden through modified Caregiver Reaction Assessment Scale Instrument

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  3. 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).

    Measured: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)

  4. 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.

    Measured: 8 weeks bereavement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2017
  2. Study start24 Jul 2017
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03089034
Sponsor's protocol ID
2016/3046
Acronym
SCOPAH
Status last verified
Feb 2025
First submitted
20 Mar 2017
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 39545423

  • 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.

    PubMed 30224389

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Heart Failure, run by Duke-NUS Graduate Medical School at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in overall quality of life among patients through the last year of life (time frame: From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03089034, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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