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Clinical Trials/NCT05407896
NCT05407896
Unknown
Not Applicable

End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)

Duke-NUS Graduate Medical School2 sites in 1 country208 target enrollmentJuly 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
End-Stage Kidney Disease
Sponsor
Duke-NUS Graduate Medical School
Enrollment
208
Locations
2
Primary Endpoint
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 1, 2021
End Date
September 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Sponsor
Duke-NUS Graduate Medical School
Responsible Party
Principal Investigator
Principal Investigator

Semra Ozdemir

Assistant Professor

Duke-NUS Graduate Medical School

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.

Outcomes

Primary Outcomes

Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)

Time Frame: 1 hour

Difference in decisional conflict scale between the intervention and comparison arms

Secondary Outcomes

  • Stated preferred treatment(Assessed after renal counselling (within 2 weeks after renal counselling))
  • Actual treatment choice(12 months after renal counselling)

Study Sites (2)

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