ENABLE (Educate, Nurture, Advise, Before Life Ends) Intervention for Heart Failure (HF) Patients and Their Caregivers in Singapore

NCT ID: NCT05211882

Last Updated: 2025-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2024-09-25

Brief Summary

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.

Detailed Description

Palliative care improves quality of life (QOL) of patients and their caregivers. The ENABLE (Educate, Nurture, Advise Before Life Ends) intervention is a novel, nurse-led, structured, palliative care coaching program, developed in the United States for patients (and caregivers of patients) facing serious illnesses. It aims to empower patients and caregivers to manage their problems, prepare for the future, and has showed beneficial impact on patient and caregiver QOL.

The ENABLE coaching program is a potentially scalable means of delivering palliative care to a large population; as compared to the current local model of palliative care provision, which uses a resource intensive multidisciplinary care model that is not easily scalable and therefore unlikely to meet the growing needs of HF patients and caregivers locally. However, it is unclear if the ENABLE HF program will be culturally acceptable and efficacious in Singapore, in view of differing socio-cultural attitudes and expectations regarding healthcare and treatments, decision making and care planning.

Overall aim - To pilot a culturally adapted version of ENABLE (6-month program) for HF patients and caregivers in the inpatient and outpatient setting in Singapore.

Specific Aim 1 - Assessment of feasibility of trial procedures in the local HF population. Intervention arm participants will start on ENABLE after randomization, while wait-list participants will start on ENABLE after 6 months. The investigators will evaluate the percentage of eligible participant dyads who consent to participate and who are able to complete the ENABLE program. The investigators will also explore the percentage completion rate of patient and caregiver reported outcome measures.

• Hypothesis: The investigators hypothesize a-priori that 80% of eligible participant dyads will consent to participate and 80% of eligible participant dyads will be able to complete the ENABLE program.

Specific aim 2 - Assessment of acceptability of ENABLE. The investigators aim to study the acceptability of ENABLE to all patient-caregiver dyads. This will be done through evaluating the total scores of a satisfaction survey of all participants at the end of ENABLE.

• Hypothesis: The investigators hypothesize that at least 80% of all participants will find the ENABLE program acceptable.

Specific aim 3 - Assessment of the possible efficacy of ENABLE. The investigators will evaluate whether there is an efficacy signal that indicates ENABLE may improve patient QOL in the local HF context.

• Hypothesis: The investigators hypothesize that patient participants randomized to the intervention arm will have more improvement in their mean QOL scores after 6 months as compared to the wait-list control group.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Immediate

Participants in the intervention arm will start on the ENABLE program at point of randomization.

Group Type: EXPERIMENTAL

Immediate ENABLE nurse coaching, on top of usual care

Intervention Type: OTHER

Participants in the intervention arm will start on the ENABLE program at point of randomization

Wait-list (delayed)

Participants on wait-list will start ENABLE 6 months after randomization.

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

Participants on wait-list will continue on usual care and only start ENABLE 6 months after randomization.

Interventions

Immediate ENABLE nurse coaching, on top of usual care

Participants in the intervention arm will start on the ENABLE program at point of randomization

Intervention Type: OTHER

Usual Care

Participants on wait-list will continue on usual care and only start ENABLE 6 months after randomization.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

1. 21 years or older.

2. Able to communicate in English or Chinese.

3. Is a direct family caregiver of the patient.

Exclusion Criteria

1. Patients who are unable to give informed consent

2. Patients who are already known to a palliative care service.

1. Caregivers who are unable to give informed consent.

2. Caregivers who are domestic helpers.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role: collaborator

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: collaborator

National Cancer Centre, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS

Role: PRINCIPAL_INVESTIGATOR

National Cancer Centre, Singapore

Locations

National Cancer Centre Singapore

Singapore, , Singapore

National Heart Centre Singapore

Singapore, , Singapore

Countries

Singapore

Other Identifiers

ENABLE

Identifier Type: -

Identifier Source: org_study_id