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Recruiting NCT07309367

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

No phase Interventional Kidney Failure, Chronic Therapy; Hemodialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: My Voice website intervention with patient and caregiver modules.
Who it may be relevant to
Registry conditions: Kidney Failure, Chronic Therapy; Hemodialysis. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

'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.

Interventions

  • Other 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 modu

Primary outcome measures

  • Quality of ACP conversations (serious illness conversations) between patients and physicians/health care providers [Time frame: Post baseline and within 8 weeks]

Eligibility criteria

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:
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Singapore · 1 center
  • Duke NUS Medical School — Singapore

Identifiers

NCT: NCT07309367 · NUS-IRB-2024-713

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗