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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Failure; Advance Care Planning
• Intervention / Treatment: Other: My Voice

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 244
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore
    • Singapore, Singapore, Singapore, 169857
      • Duke-NUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

a) domestic helper

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: My Voice; Intervention arm patients will complete the patient version of 'My Voice' at least once every 3 months for 1 year or until they pass away (whichever is earlier). Caregivers of patients in the intervention arm will complete the caregiver version of 'My Voice' at least once every 3 months for 1 year (or until the patient passes away, whichever is earlier).	Other: My Voice; 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.
No Intervention: Control; Control arm patients and caregivers will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who have ACP discussions with their treating doctor at least once during the study period	will be assessed from medical records and survey	1 year from data collection
Proportion of patients who have ACP discussions with their caregivers	will be assessed from the survey	1 year from data collection
Proportion of patients who prefer life-extending treatments	will be assessed from the survey	1 year from data collection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with psychological distress	will be assessed from the survey	1 year from data collection
Peace and acceptance scores	will be assessed from the survey	1 year from data collection
Proportion of patients having decision maker	will be assessed from the survey	1 year from data collection

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Collaborators: Khoo Teck Puat Hospital; Singapore General Hospital; Changi General Hospital; Sengkang General Hospital; National Heart Centre Singapore
• Investigators: Principal Investigator: Chetna Malhotra, Duke-NUS Graduate Medical School

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: October 13, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 16, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 2022/2482

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
• product manufactured in and exported from the U.S.: No