NCT05211882

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Feb 2022

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 2, 2022

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

February 14, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

September 3, 2025

Status Verified

September 1, 2025

Enrollment Period

2.6 years

First QC Date

January 2, 2022

Last Update Submit

September 2, 2025

Conditions

Heart Failure

Keywords

Palliative carePatientsCaregiversDistress thermometer (DT)Integrated Palliative Care Outcome Scale (IPOS)ENABLE (Educate, Nurture, Advise, Before Life Ends)

Outcome Measures

Primary Outcomes (3)

  • 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.

  • 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.

  • 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.

Study Arms (2)

Immediate

EXPERIMENTAL

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

Other: Immediate ENABLE nurse coaching, on top of usual care

Wait-list (delayed)

EXPERIMENTAL

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

Other: Usual Care

Interventions

Immediate ENABLE nurse coaching, on top of usual careOTHER

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

Immediate
Usual CareOTHER

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

Wait-list (delayed)

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • years or older.
  • Able to communicate in English or Chinese.
  • Is a direct family caregiver of the patient.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Cancer Centre Singapore

Singapore, Singapore

Location

National Heart Centre Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

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

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2022

First Posted

January 27, 2022

Study Start

February 14, 2022

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

September 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

SG(2)