Heart Failure Clinical Trial
— ENABLE-HF-SGOfficial title:
Pilot Wait-list Randomized Controlled Trial of the ENABLE (Educate, Nurture, Advise, Before Life Ends) Intervention for Heart Failure (HF) Patients and Their Caregivers in Singapore
Verified date | January 2024 |
Source | National Cancer Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To pilot a culturally adapted version of ENABLE (6-month program) for Heart Failure (HF) patients and caregivers in the inpatient and outpatient setting in Singapore. The investigators aim to determine the feasibility of trial procedures and assess the acceptability and preliminary efficacy of ENABLE with a randomized wait-list controlled trial design.
Status | Active, not recruiting |
Enrollment | 125 |
Est. completion date | March 25, 2025 |
Est. primary completion date | September 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility | Inclusion Criteria: - Inclusion criteria for patients: 1. 21 years or older. 2. Able to communicate in English or Chinese. 3. Have a diagnosis of HF (stage C or D) by the American College of Cardiology guidelines and be of New York Heart Association (NYHA) stage 2, 3 or 4 functional statuses. 4. Have an expected prognosis of at least 6 months. 5. Be on disease directed HF management. 6. Have had a hospitalization event within 6 months prior to recruitment. - Inclusion criteria for caregivers: 1. 21 years or older. 2. Able to communicate in English or Chinese. 3. Is a direct family caregiver of the patient. Exclusion Criteria: - Exclusion criteria for patients: 1. Patients who are unable to give informed consent 2. Patients who are already known to a palliative care service. - Exclusion criteria for caregivers: 1. Caregivers who are unable to give informed consent. 2. Caregivers who are domestic helpers. |
Country | Name | City | State |
---|---|---|---|
Singapore | National Cancer Centre Singapore | Singapore | |
Singapore | National Heart Centre Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Cancer Centre, Singapore | Ministry of Health, Singapore, National Medical Research Council (NMRC), Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of trial procedures - percentage of patients and caregivers that are recruited, successfully randomized, and able to complete the ENABLE program | The percentage of eligible participants that are able to be recruited, randomized and subsequently complete the ENABLE program will be calculated. | 6 months. | |
Primary | Acceptability of ENABLE program - through completion of the client satisfaction questionnaire (CSQ-4) | The total score of the CSQ-4 will be calculated for each participant. For the assessment of acceptability, scores from participants from both intervention and wait-list control groups will be pooled, except for participants who drop out prior to starting ENABLE (for reasons unrelated to the ENABLE program). The minimum expected score per participant is 4, and the maximum expected score per participant is 16. A higher score indicates higher satisfaction. | 6 months. | |
Primary | The possible efficacy of the ENABLE program- through evaluating change in patient quality of life (QOL) at 6 months as compared to baseline (assessed using the Kansas City Cardiomyopathy Questionnaire - KCCQ) | For the primary outcome of change in patient QOL, we will compare the change in the QOL from baseline to 6 months post randomization in the intervention group versus the change from baseline to 6 months post randomization in the control group. The difference between the intervention and wait-list control arm will be quantified as Cohen's d effect sizes to get an initial estimate of the efficacy of ENABLE. The minimum score on KCCQ is 0 and maximum possible score is 100. A higher score indicates a better quality of life. | 6 months. |
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