NCT07309367

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
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 Progress48%
Oct 2025Dec 2026

First Submitted

Initial submission to the registry

September 23, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

October 2, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 30, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 30, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

September 23, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Advance care planningWeb interventionDialysis withdrawal

Outcome Measures

Primary Outcomes (1)

  • 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.

    Post baseline and within 8 weeks

Other Outcomes (4)

  • Change in kidney disease and dialysis knowledge scores

    Baseline to 8 weeks

  • Change in ACP engagement

    Baseline to 8 weeks

  • Change in patient preparedness

    Baseline to 8 weeks

  • +1 more other outcomes

Study Arms (2)

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.

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.

Interventions

'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.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • 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
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke NUS Medical School

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Chandrika Ramakrishnan, MBBS; MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

September 23, 2025

First Posted

December 30, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 30, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations