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

NCT05407896 | Unknown

• 1 other identifier: 2020-SMF-0007
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 2

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.

Conditions

End-Stage Kidney Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Difference in decisional conflict scale between the intervention and comparison arms

  1 hour

Secondary Outcomes (3)

• Stated preferred treatment

  Assessed after renal counselling (within 2 weeks after renal counselling)

• Actual treatment choice

  6 months after renal counselling

• Actual treatment choice

  12 months after renal counselling

Study Arms (2)

Comparison arm

NO INTERVENTION

Patients and caregivers in this arm will receive existing counselling by trained counsellors.

Intervention arm

EXPERIMENTAL

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

Interventions

myKIDNEY decision aid OTHER

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.

Intervention arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• Singapore General Hospital: collaborator
• National University Hospital, Singapore: collaborator

Study Sites (2)

National University Hospital

Singapore, Singapore

RECRUITING

Singapore General Hospital

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Semra Ozdemir, PhD

CONTACT

66013575; semra.ozdemir@duke-nus.edu.sg

Jia Jia Lee, MPH

CONTACT

66015832; audrey.jiajia@duke-nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Pre-post study design

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: June 7, 2022
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 30, 2023
• Last Updated: June 7, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)