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

Not Applicable

Recruiting

• Conditions: Heart Failure; Advance Care Planning
• Interventions: Other: My Voice

• Registration Number: NCT06090734
• Lead Sponsor: Duke-NUS Graduate Medical School

Brief Summary

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.

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 Timeline

• Study First Submitted: 2023-10-13
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-19
• Study Start: 2024-03-07
• Status Verified: 2025-02
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-21
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 244

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
My Voice	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Duke-NUS; 🇸🇬 Singapore, Singapore