Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'

December 15, 2025 updated by: Chandrika Ramakrishnan, Duke-NUS Graduate Medical School
'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 Overview

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria: For patients

  • 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:

    1. clinical deterioration with a terminal condition or
    2. intolerability to dialysis or
    3. having two or more unplanned hospitalizations for renal complications in the past 6 months (from medical records); or
    4. known to palliative care or under conservative care as indicated in the discharge summary or
    5. 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

Inclusion Criteria: For caregivers

  • 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

Exclusion Criteria: For Patients

  • 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

Exclusion Criteria: For Caregivers

  • Those who are foreign domestic workers/maids
  • Are not easily contactable via mobile phone or landline

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

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.

'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.
No Intervention: Usual care group

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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post baseline and within 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in kidney disease and dialysis knowledge scores
Time Frame: Baseline to 8 weeks
Collected using knowledge questions designed by the research team. Higher scores indicate higher knowledge
Baseline to 8 weeks
Change in ACP engagement
Time Frame: Baseline to 8 weeks
Using the 9-item Advance care planning engagement scale. 9 to 45 (Min to Max) value, with higher value indicating higher engagement
Baseline to 8 weeks
Change in patient preparedness
Time Frame: Baseline to 8 weeks
Assessed using Preparedness for end-of-life decision-making scale. 20 to 80 (min to max) scores, with higher scores indicating better preparedness
Baseline to 8 weeks
Change in proportion of patients who had ACP conversations with family caregivers/spokesperson
Time Frame: Baseline and 8 weeks
Based on self-reported number of ACP conversations collected in the survey
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 30, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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