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Heart FailureENABLE-HF-SGNCT05211882

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

A study of Heart Failure, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 99 years
Conditions the study is for
Heart Failure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
125 participants
Where
2 sitesSingapore
Study dates
14 Feb 2022to 25 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 21 years or older.
  • Able to communicate in English or Chinese.
  • 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.
  • Have an expected prognosis of at least 6 months.
  • Be on disease directed HF management.
  • Have had a hospitalization event within 6 months prior to recruitment.
Show all 9Show fewer
  • 21 years or older.
  • Able to communicate in English or Chinese.
  • Is a direct family caregiver of the patient.

Who cannot join

  • Patients who are unable to give informed consent
  • Patients who are already known to a palliative care service.
  • Caregivers who are unable to give informed consent.
  • Caregivers who are domestic helpers.

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • National Cancer Centre Singapore

    Singapore

  • National Heart Centre Singapore

    Singapore

Other trials in Singapore

About this study

Official 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

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.

Read the 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
Being tested
Immediate ENABLE nurse coaching, on top of usual care, Usual Care
Keywords
Palliative care, Patients, Caregivers, Distress thermometer (DT), Integrated Palliative Care Outcome Scale (IPOS), ENABLE (Educate, Nurture, Advise, Before Life Ends)
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Immediate ENABLE nurse coaching, on top of usual careOther

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

  • Usual CareOther

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

Study groups in NCT05211882
Study groupRoleWhat they receive
ImmediateExperimentalParticipants in the intervention arm will start on the ENABLE program at point of randomization.
Receives: Other: Immediate ENABLE nurse coaching, on top of usual care
Wait-list (delayed)ExperimentalParticipants on wait-list will start ENABLE 6 months after randomization.
Receives: Other: Usual Care

What is being measured

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

  1. 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.

    Measured: 6 months.

  2. 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.

    Measured: 6 months.

  3. 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.

    Measured: 6 months.

Timeline

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

  1. First posted27 Jan 2022
  2. Study start14 Feb 2022
  3. Primary completion25 Sep 2024
  4. Study completion25 Sep 2024

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
125 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05211882
Sponsor's protocol ID
ENABLE
Acronym
ENABLE-HF-SG
Status last verified
Sep 2025
First submitted
2 Jan 2022
Last updated
3 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Neo SH, Ong WS, Liao K, Sim DK, Ng ESL, Foo CC, Yang Meijuan G, Odom JN, Bakitas M, Cheung YB. Feasibility, acceptability and efficacy of a nurse-led palliative care health coaching intervention (Educate, Nurture, Advise before Life Ends) for patients with heart failure and their caregivers in Singapore: a randomised wait-list controlled pilot study of health coaching in Asian heart failure. BMJ Open. 2026 May 15;16(5):e113749. doi: 10.1136/bmjopen-2025-113749.

    PubMed 42152453

  • Su-Min Y, Ng A, Neo SHS. Navigating life with heart failure: Patient and caregiver perspectives of the culturally adapted Educate, Nurture, Advise, Before Life Ends health coaching programme. Palliat Care Soc Pract. 2026 Apr 5;20:26323524261435000. doi: 10.1177/26323524261435000. eCollection 2026.

    PubMed 41947874

Questions about this trial

What is this clinical trial studying?

A study of Heart Failure, run by National Cancer Centre, Singapore at 2 sites 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 9 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: finished, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Feasibility of trial procedures - percentage of patients and caregivers that are recruited, successfully randomized, and able to complete the ENABLE program (time frame: 6 months.). The study lists 3 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 NCT05211882, 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 3 Sep 2025.

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