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

June 3, 2022 updated by: Semra Ozdemir, Duke-NUS Graduate Medical School
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

208

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Comparison arm
Patients and caregivers in this arm will receive existing counselling by trained counsellors.
Experimental: Intervention arm
Patients and caregivers in this arm will receive counselling with the newly developed web-based decision aid (myKIDNEY) by trained counsellors.
Other: myKIDNEY decision aid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stated preferred treatment
Time Frame: 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
Assessed after renal counselling (within 2 weeks after renal counselling)
Actual treatment choice
Time Frame: 6 months after renal counselling
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
6 months after renal counselling
Actual treatment choice
Time Frame: 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
12 months after renal counselling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke-NUS Graduate Medical School

Collaborators

National University Hospital, Singapore
Singapore General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

July 5, 2021

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

June 7, 2022

Last Update Submitted That Met QC Criteria

June 3, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-SMF-0007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data are available upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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