Skip to content

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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05407896
Enrollment
208
Registered
2022-06-07
Start date
2021-07-01
Completion date
2023-09-30
Last updated
2022-06-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-Stage Kidney Disease

Keywords

end-stage kidney disease, decision aid, shared decision making

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.

Interventions

OTHERmyKIDNEY 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.

Sponsors

Singapore General Hospital
CollaboratorOTHER
National University Hospital, Singapore
CollaboratorOTHER
Duke-NUS Graduate Medical School
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention model description

Pre-post study design

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)1 hourDifference in decisional conflict scale between the intervention and comparison arms

Secondary

MeasureTime frameDescription
Stated preferred treatmentAssessed 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 choice6 months after renal counsellingDifference 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

Countries

Singapore

Contacts

Primary ContactSemra Ozdemir, PhD
semra.ozdemir@duke-nus.edu.sg66013575
Backup ContactJia Jia Lee, MPH
audrey.jiajia@duke-nus.edu.sg66015832

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026