Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06090734

Development and Evaluation of 'My Voice': A Randomized Controlled Trial

The study aims to develop and evaluate a web-based interactive platform (called 'My Voice') that helps to educate patients with heart failure and their caregivers about heart failure, identify their goals for end-of-life care, and share these with their caregivers and doctors.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke-NUS

Singapore, 169857

About this study

The research study consists of 3 phases:

  • Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers,
  • Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and,
  • Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The inclusion criteria for patients are
  • Age ≥ 21 years old
  • Singaporean or Permanent Resident
  • Diagnosed with heart failure
  • Symptoms classified under NYHA class II (with an ejection fraction of less than or equal to 35%), III or IV
  • Intact cognition determined through the Abbreviated Mental Test (AMT) (for pilot testing and main RCT)
  • Ability to speak and read English, Mandarin or Malay
  • Willing to complete a web intervention
  • Easily contactable via mobile phone or landline
  • Have a permanent address in Singapore for at least the next 1 year
  • Not recruited in a previous phase of the study

The inclusion criteria for caregivers are

  • Age ≥ 21 years old
  • Nominated as a healthcare spokesperson by the patient or the main decision maker for the patient (for intervention arm only)
  • Ability to speak and read English, Mandarin or Malay
  • Willing to complete a web intervention
  • Easily contactable via mobile phone or landline
  • Have a permanent address in Singapore for at least the next 1 year

Exclusion criteria

for caregivers are:

a) domestic helper

Treatment and study plan

My Voice

Other

The web intervention educates patients about their illness and supports them to make their own Advance Care Planning decisions, update these decisions frequently as their clinical condition changes, and to make the ACP process easier and more accessible. The intervention aims to shift implementation of ACP from a provider-led one-time model to a patient-led dynamic model.

Primary outcomes

  1. Proportion of patients who have ACP discussions with their treating doctor at least once during the study period

    Time frame: 1 year from data collection

    will be assessed from medical records and survey

  2. Proportion of patients who have ACP discussions with their caregivers

    Time frame: 1 year from data collection

    will be assessed from the survey

  3. Proportion of patients who prefer life-extending treatments

    Time frame: 1 year from data collection

    will be assessed from the survey

Secondary outcomes

  1. Proportion of patients with psychological distress

    Time frame: 1 year from data collection

    will be assessed from the survey

  2. Peace and acceptance scores

    Time frame: 1 year from data collection

    will be assessed from the survey

  3. Proportion of patients having decision maker

    Time frame: 1 year from data collection

    will be assessed from the survey

Sponsors and collaborators

Lead sponsor

Duke-NUS Graduate Medical School

Other

Collaborators

  • Changi General Hospital
  • Khoo Teck Puat Hospital
  • National Heart Centre Singapore
  • Sengkang General Hospital
  • Singapore General Hospital

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 19, 2023
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.