CClinicalTrials.gg
Active, not recruitingNCT06090734Updated Apr 21, 2026

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

An interventional study of My Voice in Advance Care Planning and Heart Failure, sponsored by Duke-NUS Graduate Medical School. Active, not recruiting at 1 site in Singapore. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by Duke-NUS Graduate Medical School · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
21 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Advance Care Planning
  • Heart Failure

Browse trials for

03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 244 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Duke-NUS Graduate Medical School is the lead sponsor of 62 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion criteria for caregivers are:

a) domestic helper

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
244 participants (estimated)

Study arms

  • 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

  • No intervention
    Control

    Control arm patients and caregivers will receive usual care.

Interventions

  • OtherMy 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 1 year from data collection

  2. Proportion of patients who have ACP discussions with their caregivers

    will be assessed from the survey

    Time frame: 1 year from data collection

  3. Proportion of patients who prefer life-extending treatments

    will be assessed from the survey

    Time frame: 1 year from data collection

Secondary outcomes

  1. Proportion of patients with psychological distress

    will be assessed from the survey

    Time frame: 1 year from data collection

  2. Peace and acceptance scores

    will be assessed from the survey

    Time frame: 1 year from data collection

  3. Proportion of patients having decision maker

    will be assessed from the survey

    Time frame: 1 year from data collection

07

Study locations

1 site
  • Duke-NUS
    Singapore, Singapore 169857, Singapore
08

References and documents

Publications

  • Malhotra C, Yee A, Ramakrishnan C, Kaurani SN, Chua I, Lakin JR, Sim D, Balakrishnan I, Ling VGJ, Weiliang H, Ling LF, Pollak KI. Development and Usability of an Advance Care Planning Website (My Voice) to Empower Patients With Heart Failure and Their Caregivers: Mixed Methods Study. JMIR Aging. 2024 Dec 18;7:e60117. doi: 10.2196/60117. PubMed 39693573 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06090734
Lead sponsor
Duke-NUS Graduate Medical School
Collaborators
Changi General Hospital, Singapore General Hospital, Sengkang General Hospital, National Heart Centre Singapore, Khoo Teck Puat Hospital
Responsible party
Chetna Malhotra (Associate Professor, Duke-NUS Graduate Medical School) — Principal investigator
First posted
Oct 19, 2023
Start date
Mar 7, 2024
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Apr 21, 2026

Study contacts

Chetna Malhotra
principal investigator · Duke-NUS Graduate Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion