Kidney Failure, Chronic Therapy; HemodialysisNCT07309367
Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'
A study testing My Voice website intervention with patient and caregiver modules in people with Kidney Failure, Chronic Therapy; Hemodialysis, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
'My Voice' is a website intervention developed to enable advance care planning (ACP) conversations for patients with kidney disease on dialysis, educate patients on their illness, help identify their goals and preferences for EOL care, and coaches them on how to speak with their HCPs and loved ones. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Failure, Chronic Therapy; Hemodialysis
- What is being tested?
- My Voice website intervention with patient and caregiver modules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Oct 2025to 30 Dec 2026
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Singapore citizens or permanent residents; aged 21 years (age of majority) or older
- CKD stage 5; receiving dialysis
- Identified as eligible for SIC by NKF HCPs based on one or more of the following:
- clinical deterioration with a terminal condition or
- intolerability to dialysis or
- having two or more unplanned hospitalizations for renal complications in the past 6 months (from medical records); or
Show all 16Show fewer
- known to palliative care or under conservative care as indicated in the discharge summary or
- poor functional status indicated by the Fragility Assessment for Elders (FIFE) score >4
- Normal cognitive function as indicated by Mini Mental Scale Examination (MMSE) score of 24 or more (based on medical record)
- Able to speak and read English, Mandarin or Malay
- Agreeable to be audio-recorded
- Aged 21 years old and above
- Family caregivers of the patients recruited i.e. Caregiver primarily involved in providing care, ensuring provision of care, and/or in making decisions regarding patient's care, with no expectation of financial compensation
- Able to speak and read English, Mandarin or Malay
- Have a phone and/or an electronic device with internet access.
- Agreeable to be audio-recorded
Who cannot join
- Patients with cognitive impairment or serious mental illness will be excluded
- Patients who had prior serious illness conversations (SIC) will be excluded
- Are not easily contactable via mobile phone or landline
- Those who are foreign domestic workers/maids
- Are not easily contactable via mobile phone or landline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Duke NUS Medical School
Singapore
Chandrika Ramakrishnan, MBBS; MPH, +6566011253, chandrika.ramky@duke-nus.edu.sg
About this study
'My Voice' is a website intervention developed to enable advance care planning (ACP) conversations for patients with kidney disease on dialysis, educate patients on their illness, help identify their goals and preferences for EOL care, and coaches them on how to speak with their HCPs and loved ones. This study aims to evaluate if 'My Voice' intervention improves quality of ACP conversations between patients and providers, and patients and family carers; improves patient's knowledge about kidney failure, engagement in ACP and preparedness for future end of life care compared to usual practices for ACP in dialysis centres.
- Being tested
- My Voice website intervention with patient and caregiver modules
- Keywords
- Advance care planning, Web intervention, Dialysis withdrawal
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
My Voice website intervention with patient and caregiver modulesOther
'My Voice' is an interactive web-based ACP intervention tailored for patients with kidney failure on dialysis, and their caregivers, and includes patient and caregiver modules. Patient module has 6 steps consisting of a series of videos, value-clarification exercise (VCE) identifying goals and values for care, and knowledge quiz, and a summary My Voice document that is generated shared with patients, designated surrogates and HCPs. Automated reminders are sent to revisit My Voice. Caregiver module has 4 steps with videos and quiz, with access to their loved one's summary My Voice document containing goals of care and values.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients will view My Voice website intervention and complete patient module. They will also receive standard of care for advance care planning [namely serious illness conversation (SIC)] with the health care provider at the dialysis centers.
Caregivers will view My Voice website intervention and complete caregiver module. Receives: Other: My Voice website intervention with patient and caregiver modules |
| Usual care group | No intervention | Patients will receive standard of care for advance care planning -namely the serious illness conversation (SIC) with the health care provider at the dialysis centres. Caregivers will receive no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of ACP conversations (serious illness conversations) between patients and physicians/health care providers
Quality of ACP conversations will be measured using a scoring sheet developed for the study. One point will be given for every SICG topic discussed with score min to max of 0 to 13. Higher scores indicate higher quality.
Measured: Post baseline and within 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start2 Oct 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, Chronic Therapy; HemodialysisStudies 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- National Kidney Foundation, Singapore
- Responsible party
- Principal investigator, Chandrika Ramakrishnan, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309367
- Sponsor's protocol ID
- NUS-IRB-2024-713
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'
- ClinicalTrials.gov ID
- NCT07309367
- Acronym / sponsor ID
- NUS-IRB-2024-713
- Keywords
- Advance care planning, Web intervention, Dialysis withdrawal
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- National Kidney Foundation, Singapore
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Dec 2025 (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.
'My Voice' is a website intervention developed to enable advance care planning (ACP) conversations for patients with kidney disease on dialysis, educate patients on their illness, help identify their goals and preferences for EOL care, and coaches them on how to speak with their HCPs and loved ones. This study aims to evaluate if 'My Voice' intervention improves quality of ACP conversations between patients and providers, and patients and family carers; improves patient's knowledge about kidney failure, engagement in ACP and preparedness for future end of life care compared to usual practices for ACP in dialysis centres.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: My Voice website intervention with patient and caregiver modulesPatients will view My Voice website intervention and complete patient module. They will also receive standard of care for advance care planning [namely serious illness conversation (SIC)] with the health care provider at the dialysis centers. Caregivers will view My Voice website intervention and complete caregiver module. |
| Usual care group | No intervention | –Patients will receive standard of care for advance care planning -namely the serious illness conversation (SIC) with the health care provider at the dialysis centres. Caregivers will receive no intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Singapore citizens or permanent residents; aged 21 years (age of majority) or older
- CKD stage 5; receiving dialysis
- Identified as eligible for SIC by NKF HCPs based on one or more of the following:
- Normal cognitive function as indicated by Mini Mental Scale Examination (MMSE) score of 24 or more (based on medical record)
- Able to speak and read English, Mandarin or Malay
Key exclusion criteria (5 listed)
- Patients with cognitive impairment or serious mental illness will be excluded
- Patients who had prior serious illness conversations (SIC) will be excluded
- Are not easily contactable via mobile phone or landline
- Those who are foreign domestic workers/maids
- Are not easily contactable via mobile phone or landline
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 Voice website intervention with patient and caregiver modules'My Voice' is an interactive web-based ACP intervention tailored for patients with kidney failure on dialysis, and their caregivers, and includes patient and caregiver modules. Patient module has 6 steps consisting of a series of videos, value-clarification exercise (VCE) identifying goals and values for care, and knowledge quiz, and a summary My Voice document that is generated shared with patients, designated surrogates and HCPs. Automated reminders are sent to revisit My Voice. Caregiver module has 4 steps with videos and quiz, with access to their loved one's summary My Voice document containing goals of care and values. | Other | Intervention group |
Primary outcome
Quality of ACP conversations (serious illness conversations) between patients and physicians/health care providers
Time frame: Post baseline and within 8 weeks
Quality of ACP conversations will be measured using a scoring sheet developed for the study. One point will be given for every SICG topic discussed with score min to max of 0 to 13. Higher scores indicate higher quality.
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 30 Dec 2025.
- Individual participant dataSharing planned: No
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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.
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 website intervention with patient and caregiver modules in people with Kidney Failure, Chronic Therapy; Hemodialysis, 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 16 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 30 Dec 2025. 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?
Contact Chandrika Ramakrishnan, MBBS; MPH (+6566011253, chandrika.ramky@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of ACP conversations (serious illness conversations) between patients and physicians/health care providers (time frame: Post baseline and within 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2025.