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

Not Applicable

• Conditions: End-Stage Kidney Disease
• Interventions: Other: myKIDNEY decision aid

• Registration Number: NCT05407896
• Lead Sponsor: Duke-NUS Graduate Medical School

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.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-07-05
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-03
• Last Update Submitted: 2022-06-03
• Study First Posted: 2022-06-07
• Last Update Posted: 2022-06-07
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention arm	myKIDNEY decision aid	Patients and caregivers in this arm will receive counselling with the newly developed web-based decision aid (myKIDNEY) by trained counsellors.

Primary Outcome Measures

Name	Time	Method
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)	1 hour	Difference in decisional conflict scale between the intervention and comparison arms

Secondary Outcome Measures

Name	Time	Method
Stated preferred treatment	Assessed after renal counselling (within 2 weeks after renal counselling)	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	12 months after renal counselling	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

Trial Locations

Locations (2)

Singapore General Hospital; 🇸🇬 Singapore, Singapore

National University Hospital; 🇸🇬 Singapore, Singapore