A web-based platform to help heart failure patients with advance care planning
Development and Evaluation of 'My Voice': a Randomized Controlled Trial
This study is testing a new online tool called 'My Voice' to help heart failure patients and their caregivers better understand their condition and communicate their end-of-life care wishes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 244 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Duke-NUS Graduate Medical School Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06090734 on ClinicalTrials.gov |
What this trial studies
This study develops and evaluates 'My Voice', an interactive web-based platform designed to educate heart failure patients and their caregivers about the condition. It involves three phases: usability testing to assess the platform's effectiveness, pilot testing to evaluate implementation feasibility, and a randomized controlled trial comparing outcomes between users of 'My Voice' and a control group. The goal is to improve communication about end-of-life care preferences between patients, caregivers, and healthcare providers.
Who should consider this trial
Good fit: Ideal candidates include Singaporean or Permanent Resident adults aged 21 and older diagnosed with heart failure and experiencing specific symptoms.
Not a fit: Patients who do not meet the inclusion criteria, such as those outside the specified age range or without a heart failure diagnosis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this platform could enhance the quality of end-of-life care for heart failure patients by facilitating better communication of their preferences.
How similar studies have performed: Other studies have shown success with similar web-based interventions for chronic disease management, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Singapore
- Duke-NUS — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Chetna Malhotra — Duke-NUS Graduate Medical School
- Study coordinator: Chetna Malhotra, MD, MPH
- Email: chetna.malhotra@duke-nus.edu.sg
- Phone: +65 65165692
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.