Development and Evaluation of 'My Voice': a Randomized Controlled Trial
NCT ID: NCT06090734
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
244 participants
INTERVENTIONAL
2024-03-07
2026-02-28
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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).
My 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.
Control
Control arm patients and caregivers will receive usual care.
No interventions assigned to this group
Interventions
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My 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.
Eligibility Criteria
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Inclusion Criteria
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
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
21 Years
ALL
No
Sponsors
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Changi General Hospital
OTHER
Singapore General Hospital
OTHER
Sengkang General Hospital
OTHER
National Heart Centre Singapore
OTHER
Khoo Teck Puat Hospital
OTHER
Duke-NUS Graduate Medical School
OTHER
Responsible Party
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Chetna Malhotra
Associate Professor
Principal Investigators
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Chetna Malhotra
Role: PRINCIPAL_INVESTIGATOR
Duke-NUS Graduate Medical School
Locations
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Duke-NUS
Singapore, Singapore, Singapore
Countries
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Central Contacts
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Other Identifiers
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2022/2482
Identifier Type: -
Identifier Source: org_study_id
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