End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
Primary Purpose
End-Stage Kidney Disease
Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
myKIDNEY decision aid
Sponsored by
About this trial
This is an interventional health services research trial for End-Stage Kidney Disease focused on measuring end-stage kidney disease, decision aid, shared decision making
Eligibility Criteria
Inclusion Criteria (patients):
- Incident CKD Stage 5 patients with GFR<15ml/min
- Aged 70 years or older-
- Have not undergone counselling with a renal counsellor
- Cognitively intact as determined by the Abbreviated Mental Test (AMT)
- Speak and read English or Mandarin
Inclusion Criteria (caregivers):
- Primary informal caregiver for an eligible patient (primarily involved in providing care, ensuring provision of care, and/or in making decisions regarding patient's care)
- Aged 21 years and older
- Direct relative of the patient
Exclusion Criteria:
- Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.
Sites / Locations
- National University HospitalRecruiting
- Singapore General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Comparison arm
Intervention arm
Arm Description
Patients and caregivers in this arm will receive existing counselling by trained counsellors.
Patients and caregivers in this arm will receive counselling with the newly developed web-based decision aid (myKIDNEY) by trained counsellors.
Outcomes
Primary Outcome Measures
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)
Difference in decisional conflict scale between the intervention and comparison arms
Secondary Outcome Measures
Stated preferred treatment
Difference in the percentage of participants who choose a form of dialysis as the preferred treatment between the intervention and comparison arms
Actual treatment choice
Difference in the percentage of participants who initiate dialysis based on the medical records at 6 months after the counselling between the intervention and comparison arms
Actual treatment choice
Difference in the percentage of participants who initiate dialysis based on the medical records at 12 months after the counselling between the intervention and comparison arms
Full Information
NCT ID
NCT05407896
First Posted
July 5, 2021
Last Updated
June 3, 2022
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore General Hospital, National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT05407896
Brief Title
End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
Official Title
End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Singapore General Hospital, National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Decision aids are highly recommended for decisions when there is no "right" treatment choice. The goal is to help patients choose a treatment that is consistent with their preferences and to minimize decisional conflict and regret. A case where there is no "right" treatment concerns the decision to undergo dialysis or supportive care (i.e., conservative management) for elderly (aged ≥70) patients with end-stage kidney disease. The investigators propose to develop an interactive web-based decision aid and test its effectiveness via a pre-post study design. This research aims to reduce decisional conflict for elderly ESKD patients and caregivers.
Detailed Description
For patients aged 75 and above with comorbidities, the benefits of dialysis over kidney supportive care, which focuses on maintaining quality of life as opposed to life extension, are not clear. As there is no clear or "right" treatment choice, treatment decisions should be informed by patient preferences. However, currently in Singapore most patients choose dialysis and express decisional conflict and regret. Decision aids (DAs) together with values clarification methods (VCMs) can help patients choose a treatment that is concordant with their preferences and treatment goals. To help minimize decisional conflict among elderly ESKD patients, the first aim of this proposal is to adapt the current materials the investigators have developed (booklet and video) for elderly ESKD patients in a prior effort (NMRC/HSRG/0080/2017) into an interactive web-based tool called myKIDNEY. It will provide patients with tailored and relevant information based on their age and medical history, and help them identify and express their preferences via an interactive VCM. The second aim of the proposal is to test the benefits of counselling with myKIDNEY to standard renal counselling via a pre-post study design. The primary hypothesis is that patients and caregivers who receive counselling with myKIDNEY will report less decisional conflict compared to those who receive standard counselling. The investigators also hypothesize that fewer patients in the intervention arm will opt for dialysis, which is the more costly and invasive treatment option. If the proposed study shows evidence that the interactive tool improves decision-making quality in the local setting, this will result in a better patient experience. If fewer patients choose dialysis as per our hypothesis, this will also generate cost savings for the health system while at the same time allowing patients to choose their preferred treatment with lower chances of decisional conflict.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Kidney Disease
Keywords
end-stage kidney disease, decision aid, shared decision making
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Pre-post study design
Masking
Participant
Allocation
Non-Randomized
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comparison arm
Arm Type
No Intervention
Arm Description
Patients and caregivers in this arm will receive existing counselling by trained counsellors.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
Patients and caregivers in this arm will receive counselling with the newly developed web-based decision aid (myKIDNEY) by trained counsellors.
Intervention Type
Other
Intervention Name(s)
myKIDNEY decision aid
Intervention Description
Patients and caregivers will be counselled using myKIDNEY decision aid which includes a video. Patients will be asked to complete a values clarification exercise (VCE). If a caregiver is recruited without their patient, he/she will be asked to complete the VCE on patient's behalf (i.e., surrogate). At the end of VCE, the participant will be given real-time feedback on which treatment might be the best fit for the patient. With the patient's consent, this information will be shared with the treating physician who can then make recommendations based on the patient's preferences.
Primary Outcome Measure Information:
Title
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)
Description
Difference in decisional conflict scale between the intervention and comparison arms
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Stated preferred treatment
Description
Difference in the percentage of participants who choose a form of dialysis as the preferred treatment between the intervention and comparison arms
Time Frame
Assessed after renal counselling (within 2 weeks after renal counselling)
Title
Actual treatment choice
Description
Difference in the percentage of participants who initiate dialysis based on the medical records at 6 months after the counselling between the intervention and comparison arms
Time Frame
6 months after renal counselling
Title
Actual treatment choice
Description
Difference in the percentage of participants who initiate dialysis based on the medical records at 12 months after the counselling between the intervention and comparison arms
Time Frame
12 months after renal counselling
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (patients):
Incident CKD Stage 5 patients with GFR<15ml/min
Aged 70 years or older-
Have not undergone counselling with a renal counsellor
Cognitively intact as determined by the Abbreviated Mental Test (AMT)
Speak and read English or Mandarin
Inclusion Criteria (caregivers):
Primary informal caregiver for an eligible patient (primarily involved in providing care, ensuring provision of care, and/or in making decisions regarding patient's care)
Aged 21 years and older
Direct relative of the patient
Exclusion Criteria:
- Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Semra Ozdemir, PhD
Phone
66013575
Email
semra.ozdemir@duke-nus.edu.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Jia Lee, MPH
Phone
66015832
Email
audrey.jiajia@duke-nus.edu.sg
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boon Wee Teo
Email
mdctbw@nus.edu.sg
Facility Name
Singapore General Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Choong
Email
Lina.choong.h.l@sgh.com.sg
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data are available upon reasonable request.
Learn more about this trial
End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
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