End-Stage Kidney DiseaseNCT05407896
End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
A study testing myKIDNEY decision aid in people with End-Stage Kidney Disease, run by Duke-NUS Graduate Medical School at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-Stage Kidney Disease
- What is being tested?
- myKIDNEY decision aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Jul 2021to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore
Boon Wee Teo, mdctbw@nus.edu.sg
- Recruiting
Singapore General Hospital
Singapore
Lina Choong, Lina.choong.h.l@sgh.com.sg
About this study
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.
Read the 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.
- Conditions
- End-Stage Kidney Disease
- Being tested
- myKIDNEY decision aid
- Keywords
- end-stage kidney disease, decision aid, shared decision making
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myKIDNEY decision aidOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: myKIDNEY decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict)
Difference in decisional conflict scale between the intervention and comparison arms
Measured: 1 hour
Secondary outcomes (3)
Stated preferred treatment
Difference in the percentage of participants who choose a form of dialysis as the preferred treatment between the intervention and comparison arms
Measured: Assessed after renal counselling (within 2 weeks after renal counselling)
Actual treatment choice
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
Measured: 6 months after renal counselling
Actual treatment choice
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
Measured: 12 months after renal counselling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jul 2021
- Primary completion1 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Pre-post study design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital, National University Hospital, Singapore
- Responsible party
- Principal investigator, Semra Ozdemir, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05407896
- Sponsor's protocol ID
- 2020-SMF-0007
- Status last verified
- Jun 2022
- First submitted
- 5 Jul 2021
- Last updated
- 7 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- End-Stage Kidney Disease Interactive Decision Aid for the Elderly (myKIDNEY)
- ClinicalTrials.gov ID
- NCT05407896
- Acronym / sponsor ID
- 2020-SMF-0007
- Conditions
- End-Stage Kidney Disease
- Keywords
- end-stage kidney disease, decision aid, shared decision making
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- Singapore General Hospital, National University Hospital, Singapore
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 7 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Pre-post study design
| Arm | Type | Receives |
|---|---|---|
| Comparison arm | No intervention | –Patients and caregivers in this arm will receive existing counselling by trained counsellors. |
| Intervention arm | Experimental | Other: myKIDNEY decision aidPatients and caregivers in this arm will receive counselling with the newly developed web-based decision aid (myKIDNEY) by trained counsellors. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Patients deemed to be mentally incompetent, and those not aware of their diagnosis will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myKIDNEY decision aidPatients 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. | Other | Intervention arm |
Primary outcome
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
3 secondary outcomes
Stated preferred treatment
Time frame: Assessed after renal counselling (within 2 weeks after renal counselling)
Actual treatment choice
Time frame: 6 months after renal counselling
Actual treatment choice
Time frame: 12 months after renal counselling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
- Individual participant dataSharing planned: No. Data are available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myKIDNEY decision aid in people with End-Stage Kidney Disease, run by Duke-NUS Graduate Medical School at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Semra Ozdemir, PhD (66013575, semra.ozdemir@duke-nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decisional conflict scale (0 to 100; higher scores indicate higher decisional conflict) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2022.