NCT06090734

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Mar 2024Mar 2027

First Submitted

Initial submission to the registry

October 13, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

October 13, 2023

Last Update Submit

April 16, 2026

Conditions

Advance Care PlanningHeart Failure

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Proportion of patients with psychological distress

    1 year from data collection

  • Peace and acceptance scores

    1 year from data collection

  • Proportion of patients having decision maker

    1 year from data collection

Study Arms (2)

My Voice

EXPERIMENTAL

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

Control

NO INTERVENTION

Control arm patients and caregivers will receive usual care.

Interventions

My VoiceOTHER

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.

My Voice

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • a) domestic helper

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke-NUS

Singapore, Singapore, 169857, Singapore

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Chetna Malhotra

    Duke-NUS Graduate Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 13, 2023

First Posted

October 19, 2023

Study Start

March 7, 2024

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)