Advance Care PlanningNCT06090734
Development and Evaluation of 'My Voice': A Randomized Controlled Trial
A study testing My Voice in people with Advance Care Planning and Heart Failure, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial 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 more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Advance Care Planning, Heart Failure
- What is being tested?
- My Voice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 1 siteSingapore
- Study dates
- 7 Mar 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 18Show fewer
- 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
Who cannot join
- domestic helper
Trial locations and contacts
1 site in 1 country.
About this study
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:
- Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers,
- Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and,
- 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
- Advance Care Planning, Heart Failure
- Being tested
- My Voice
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: My Voice |
| Control | No intervention | Control arm patients and caregivers will receive usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year from data collection
Proportion of patients who have ACP discussions with their caregivers
will be assessed from the survey
Measured: 1 year from data collection
Proportion of patients who prefer life-extending treatments
will be assessed from the survey
Measured: 1 year from data collection
Secondary outcomes (3)
Proportion of patients with psychological distress
will be assessed from the survey
Measured: 1 year from data collection
Peace and acceptance scores
will be assessed from the survey
Measured: 1 year from data collection
Proportion of patients having decision maker
will be assessed from the survey
Measured: 1 year from data collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start7 Mar 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advance Care PlanningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Changi General Hospital, Singapore General Hospital, Sengkang General Hospital, National Heart Centre Singapore, Khoo Teck Puat Hospital
- Responsible party
- Principal investigator, Chetna Malhotra, Duke-NUS Graduate Medical School
- Investigators
- Chetna Malhotra, Principal investigator, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090734
- Sponsor's protocol ID
- 2022/2482
- Status last verified
- Apr 2026
- First submitted
- 13 Oct 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of 'My Voice': A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06090734
- Acronym / sponsor ID
- 2022/2482
- Conditions
- Advance Care Planning, Heart Failure
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Changi General Hospital, Singapore General Hospital, Sengkang General Hospital, National Heart Centre Singapore, Khoo Teck Puat Hospital
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The research study consists of 3 phases:
- Usability testing - to assess the usability of 'My Voice' with patients with heart failure, their caregivers and healthcare providers,
- Pilot testing - to test the feasibility of implementation and workflow of 'My Voice' and the survey questionnaires with a small group of participants and,
- Randomized controlled trial- to evaluate the effectiveness of 'My Voice' with a control group who do not receive the intervention in improving patient outcomes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| My Voice | Experimental | Other: My VoiceIntervention 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). |
| Control | No intervention | –Control arm patients and caregivers will receive usual care. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (1 listed)
- domestic helper
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| My VoiceThe 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. | Other | My Voice |
Primary outcome
Proportion of patients who have ACP discussions with their treating doctor at least once during the study period
Time frame: 1 year from data collection
will be assessed from medical records and survey
Proportion of patients who have ACP discussions with their caregivers
Time frame: 1 year from data collection
will be assessed from the survey
Proportion of patients who prefer life-extending treatments
Time frame: 1 year from data collection
will be assessed from the survey
3 secondary outcomes
Proportion of patients with psychological distress
Time frame: 1 year from data collection
Peace and acceptance scores
Time frame: 1 year from data collection
Proportion of patients having decision maker
Time frame: 1 year from data collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Derived from this study: PubMed 39693573Malhotra 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.
- Individual participant dataSharing planned: No
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Using a Conversation Game to Engage Native American Washoe Tribe Members in Advance Care Planning: Preparation for a Clinical Trial
Advance Care Planning, American Indian or Alaska Native
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Development and Evaluation of a Disease-oriented Scenario Game to Promote ACP Among Older Adults and Family Caregivers
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Longitudinal Early Advance Care Planning Discussions and Documentation (LEADD) Program: An Exploratory Study in Adolescents and Young Adults (AYAs) Receiving Hematopoietic Stem Cell Transplant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chetna Malhotra principal investigator
Duke-NUS Graduate Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing My Voice in people with Advance Care Planning and Heart Failure, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have ACP discussions with their treating doctor at least once during the study period (time frame: 1 year from data collection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.