Chronic Kidney DiseasesNCT06597279
Developing Tools for Dialysis Decision Support
A study testing Web-based dialysis decision support tool in people with Chronic Kidney Diseases, run by VA Palo Alto Health Care System at 2 sites in United States.
Trial summary
The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Web-based dialysis decision support tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Nov 2024to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age \>=65
- Estimated GFR \<25 ml/min/1.73m2
- English speaking
- Not a candidate for kidney transplant based on nephrologist assessment.
- Family/caregiver inclusion criteria:
- age \>=21
- English speaking
Who cannot join
- Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
U.S. Department of Veterans Affairs - Palo Alto Health Care System
Palo Alto, California, 94304
Stanford Health Care
Stanford, California, 94305
About this study
The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.
Read the detailed description
This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Web-based dialysis decision support tool
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-based dialysis decision support toolBehavioural
The intervention in this study is the "Kidney Care Roadmap", a web-based dialysis decision support tool designed to assist patients with advanced chronic kidney disease and their caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Web-based dialysis decision support tool Receives: Behavioral: Web-based dialysis decision support tool |
| Control | No intervention | Historical controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment choice
Proportion of patients who are undecided about treatment choice.
Measured: 1 month
Values treatment concordance
Change in values treatment concordance.
Measured: 1 month
Confidence in treatment decision
Confidence in kidney failure treatment decision
Measured: 1 month
Treatment choice
Proportion of patients who choose medical management without dialysis
Measured: 1 month
Decisional Conflict Scale (DCS)
Change in the decisional conflict scale (DCS) score from baseline to follow-up. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start21 Nov 2024
- Primary completion10 Apr 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a non-randomized controlled trial using historical control as a comparator. It involves comparing outcomes from a group of participants receiving the current intervention with outcomes from a previously treated group (historical control) that did not receive the intervention.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Palo Alto Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Manjula Kurella Tamura, MD, MPH, VA Palo Alto Health Care System
- Investigators
- Manjula Tamura, MD, MPH, Principal investigator, U.S. Department of Veterans Affairs - Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597279
- Sponsor's protocol ID
- IRB-54542
- Other IDs
- HX002763
- Status last verified
- Aug 2025
- First submitted
- 6 Sep 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Tools for Dialysis Decision Support
- ClinicalTrials.gov ID
- NCT06597279
- Acronym / sponsor ID
- IRB-54542
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- VA Palo Alto Health Care SystemUS federal agency
- Study start
- 21 Nov 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (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.
The aim of this study is to evaluate the impact of a web-based dialysis decision support tool on decisional conflict, and values-treatment concordance and other decisional outcomes in individuals with advanced chronic kidney disease, and to assess the tool's acceptability and usability.
Detailed description
This study employs a pre-post design to assess the impact of a web-based dialysis decision support tool on patients with advanced chronic kidney disease and their caregivers. Participants will complete baseline surveys assessing demographics, knowledge of kidney failure treatments, and decisional conflict during a nephrology clinic visit. Following the visit, participants will access the decision support tool, with follow-up support provided by the study coordinator. One to four weeks after the baseline visit, participants will complete follow-up surveys to re-evaluate knowledge, decisional conflict, values-treatment concordance, and the quality of shared decision-making. Additionally, telephone interviews will be conducted to explore participants' understanding of treatment options and gather feedback on the decision support tool.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-randomized controlled trial using historical control as a comparator. It involves comparing outcomes from a group of participants receiving the current intervention with outcomes from a previously treated group (historical control) that did not receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Web-based dialysis decision support toolWeb-based dialysis decision support tool |
| Control | No intervention | –Historical controls |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age \>=65
- Estimated GFR \<25 ml/min/1.73m2
- English speaking
- Not a candidate for kidney transplant based on nephrologist assessment.
- age \>=21
Key exclusion criteria (1 listed)
- Patients with cognitive impairment will be excluded; however their family member or caregiver is eligible to participate.
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 |
|---|---|---|
| Web-based dialysis decision support toolThe intervention in this study is the "Kidney Care Roadmap", a web-based dialysis decision support tool designed to assist patients with advanced chronic kidney disease and their caregivers. | Behavioural | Intervention |
Primary outcome
Treatment choice
Time frame: 1 month
Proportion of patients who are undecided about treatment choice.
Values treatment concordance
Time frame: 1 month
Change in values treatment concordance.
Confidence in treatment decision
Time frame: 1 month
Confidence in kidney failure treatment decision
Treatment choice
Time frame: 1 month
Proportion of patients who choose medical management without dialysis
Decisional Conflict Scale (DCS)
Time frame: 1 month
Change in the decisional conflict scale (DCS) score from baseline to follow-up. Scores range from 0 [no decisional conflict] to 100 [extremely high decisional conflict].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Manjula Tamura, MD, MPH principal investigator
U.S. Department of Veterans Affairs - Palo Alto Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-based dialysis decision support tool in people with Chronic Kidney Diseases, run by VA Palo Alto Health Care System at 2 sites in United States.
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 7 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: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment choice (time frame: 1 month). The study lists 5 primary outcomes in all. 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 22 Aug 2025.