Status:
RECRUITING
Development and Evaluation of 'My Voice': a Randomized Controlled Trial
Lead Sponsor:
Duke-NUS Graduate Medical School
Collaborating Sponsors:
Changi General Hospital
Singapore General Hospital
Conditions:
Advance Care Planning
Heart Failure
Eligibility:
All Genders
21+ years
Phase:
NA
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 g...
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 - t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
244 Patients enrolled
Trial Details
Trial ID
NCT06090734
Start Date
March 7 2024
End Date
February 1 2026
Last Update
March 21 2025
Active Locations (1)
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1
Duke-NUS
Singapore, Singapore, Singapore, 169857