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

January 31, 2024 updated by: National Cancer Centre, Singapore

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

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, Singapore
        • National Cancer Centre Singapore
      • Singapore, Singapore
        • 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 to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate
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
Participants in the intervention arm will start on the ENABLE program at point of randomization
Experimental: Wait-list (delayed)
Participants on wait-list will start ENABLE 6 months after randomization.
Other: Usual Care
Participants on wait-list will continue on usual care and only start ENABLE 6 months after randomization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 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)
Time Frame: 6 months.
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)
Time Frame: 6 months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

National Medical Research Council (NMRC), Singapore
Ministry of Health, Singapore

Investigators

  • Principal Investigator: Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS, National Cancer Centre, Singapore

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)

February 14, 2022

Primary Completion (Estimated)

September 25, 2024

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

January 2, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (Actual)

January 27, 2022

Study Record Updates

Last Update Posted (Estimated)

February 1, 2024

Last Update Submitted That Met QC Criteria

January 31, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENABLE

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.

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