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

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

Recruiting
21 years and older
All
Phase N/A

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Overview

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.

Description

The research study consists of 3 phases:

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

Eligibility

Inclusion Criteria:

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

The inclusion criteria for caregivers are

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

Exclusion criteria for caregivers are:

  1. domestic helper

Study details
    Advance Care Planning
    Heart Failure

NCT06090734

Duke-NUS Graduate Medical School

31 August 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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