- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03089034
Singapore Cohort of Patients With Advanced Heart Failure (SCOPAH)
October 15, 2023 updated by: Eric A. Finkelstein, Duke-NUS Graduate Medical School
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.
Study Overview
Status
Active, not recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 169609
- National Heart Centre Singapore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
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
Time Frame: 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
|
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
Time Frame: 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
|
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
Time Frame: 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.
|
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
Time Frame: 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)
|
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
Time Frame: 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
|
From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
|
Change in patients' cognitive status
Time Frame: 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
|
From recruitment to death of patient (baseline, 4 month, 8 months, 12 months, 16 months, 20 months, 24 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in patient's awareness of hospice palliative care services among heart failure patients
Time Frame: 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.
|
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
Time Frame: 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
|
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
Time Frame: 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).
|
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
Time Frame: 8 weeks bereavement
|
Investigators will assess caregiver perceived quality of end-of-life care through CEQUEL.
|
8 weeks bereavement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 24, 2017
Primary Completion (Estimated)
October 31, 2025
Study Completion (Estimated)
October 31, 2025
Study Registration Dates
First Submitted
March 20, 2017
First Submitted That Met QC Criteria
March 20, 2017
First Posted (Actual)
March 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 15, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/3046
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Heart Failure
-
Maastricht University Medical CenterUniversity College Dublin; RWTH Aachen University; Queen's University, BelfastCompletedChronic Heart FailureNetherlands, Germany, Ireland, United Kingdom
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Jordan Cardio Vascular Research GroupRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureJordan
-
Lithuanian University of Health SciencesCompletedHeart Failure | Chronic Heart Failure | Congestive Heart Failure | Right Ventricular FailureLithuania
-
Zensun Sci. & Tech. Co., Ltd.RecruitingChronic Heart FailureChina
-
University Hospital, Clermont-FerrandHospices Civils de Lyon; University Hospital, Grenoble; Hôpital de la Croix-Rousse and other collaboratorsRecruitingHeart Failure | Chronic Heart Failure | Acute Heart FailureFrance
-
University of Roma La SapienzaUnknownChronic Heart Failure | Decompensated Heart Failure | Morality
-
University Medicine GreifswaldDeutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)RecruitingChronic Heart FailureGermany
-
AquaPass Medical Ltd.CompletedChronic Heart FailureIsrael
-
University Hospital, Gentofte, CopenhagenUnknownChronic Heart Failure | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure NYHA Class IVDenmark