- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07309367
Web-based Advance Care Planning Intervention for Patients With Kidney Failure on Dialysis: Pilot Testing of 'My Voice'
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chandrika Ramakrishnan, MBBS; MPH
- Phone Number: +6566011253
- Email: chandrika.ramky@duke-nus.edu.sg
Study Locations
-
-
-
Singapore, Singapore
- Recruiting
- Duke NUS Medical School
-
Contact:
- Chandrika Ramakrishnan, MBBS; MPH
- Phone Number: +6566011253
- Email: chandrika.ramky@duke-nus.edu.sg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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:
- 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
Study Plan
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
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NUS-IRB-2024-713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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