Chronic Kidney DiseaseAINCT06533254
Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake
An observational study of Chronic Kidney Disease, run by Scaled Insights at 1 site in United States.
Trial summary
Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis Scaled Insights' can utilize the data from this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Predicting choice of dialysis and Behavioral nudges
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2024to 31 Dec 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: There are two phases in this study. Phase 1: 2000 participants in total. 1000 in the USA, and 1000 in the UK; 500 patients who predict they will choose peritoneal dialysis and 500 who predict they will choose hemodialysis in each country. Patients who agree to participate in the study, will consent using an online survey disseminated to patients with Chronic Kidney Disease stage 4-5. Where needed, participants can be supported to complete the survey by a Research Nurse/Assistant to complete the survey. Phase 2: 1000 Patients with Chronic Kidney Disease in total. 500 in the USA and 500 in the UK. Patients who agree to participate in the study. They will be asked to access a link to an online web platform where the study will be hosted.
Who may be able to join
- Phase 1: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.
- Phase 2: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.
Who cannot join
- Phase 1: Young people aged \<18 years. People who do not have Chronic Kidney Disease. People who reside outside of the USA and UK.
- Phases 2: Young people aged \<18 years. People who do not have Chronic Kidney Disease stage 4-5. People who reside outside of the USA and UK.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Dallas Renal Group
Dallas, Texas, 75230
Veronica Almanza, 214-697-7187, valmanza@dallasrenalgroup.com
Kim Adams, 214-697-7187, kim.adams@dallasrenalgroup.com
About this study
Official title: Use of Behavioral Artificial Intelligence to Predict and Increase Uptake of Peritoneal Dialysis [AI-Dialysis]
Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis
Scaled Insights' can utilize the data from this study to develop individualized nudges for healthcare professionals that can be broadly deployed within a digital platform so that clinics across the English speaking world can use it as a means of supporting patients with CKD in selecting peritoneal dialysis treatment.
Read more
Using Scaled Insights novel Behavioral Artificial Intelligence solution, the proposed project has two aims:
- to identify personality attributes of patients with Chronic Kidney Disease and correlating their personality attributes with their subsequent choice of dialysis. Once correlated into personality based clusters, the AI Model will then be able will determine which personality cluster each net new patient will fall into and therefore predict their specific likelihood of opting for peritoneal dialysis or hemodialysis
- once prediction is possible, customized nudges towards the selection of PD will be developed and tested to improve the likelihood that patients will opt for peritoneal dialysis
Hypotheses:
- Scaled Insights Behavioral AI will identify the personality characteristics of patients with Chronic Kidney Disease who are likely to opt for both peritoneal dialysis and hemodialysis (Phase 1)
- Scaled Insights Behavioral AI will identify the nudges that are most effective in encouraging or supporting patients with Chronic Kidney Disease in choosing peritoneal dialysis over hemodialysis (Phase 2)
- Conditions
- Chronic Kidney Disease
- Being tested
- Predicting choice of dialysis, Behavioral nudges
- Keywords
- Chronic Kidney Disease, Artificial Intelligence, Dialysis
- 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.
Predicting choice of dialysisOther
Language data collected using survey 1, will be analyzed using Scaled Insights Behavioral AI solution to identify personality attributes and values. The resulting individual scores will be plotted on a graph and be used to identify specific personality clusters of patients.
Participants will respond to a survey that utilizes open and closed ended questions, asking broad questions about kidney failure and associated behaviors (e.g. diet, attitudes towards treatment). The open-ended questions will gather a natural language sample of 100-300 words whilst closed questions will capture data using Likert scale and multiple-choice responses.
The open-ended questions will gather a natural language sample of 100-300 words for analysis using Scaled Insights Behavioral AI approach. This language sample will be analyzed using Scaled Insights Behavioral AI system to identify personality attributes and values. Patients will also be asked their likelihood of selecting PD over HD.
Behavioral nudgesBehavioural
Patients with Chronic Kidney Disease, participants will be provided with their predicted personalized nudge to increase their likelihood of either maintaining their choice of peritoneal dialysis, or switching from hemodialysis to peritoneal dialysis.
Participants will respond to a survey that utilizes open and closed ended questions, asking broad questions about kidney failure and associated behaviors (e.g. diet, attitudes towards treatment). The open-ended questions will gather a natural language sample of 100-300 words whilst closed questions will capture data using Likert scale and multiple-choice responses.
| Study group | Role | What they receive |
|---|---|---|
| Patients who have Chronic Kidney Disease (Phase 1) | Patients who have Chronic Kidney Disease attending clinics managed by Dallas Renal Group in Texas USA, Leeds Teaching Hospitals NHS Trust UK and Suffolk and North East Essex NHS Trust UK will be contacted via their health care provider to invite them to participate. Receives: Other: Predicting choice of dialysis | |
| Patients who have Chronic Kidney Disease (Phase 2) | Patients who have Chronic Kidney Disease and are attending the units managed by Dallas Renal Group in Texas USA, Leeds Teaching Hospitals NHS Trust UK and Suffolk and North East Essex NHS Trust UK. Receives: Behavioral: Behavioral nudges |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of Dyalysis
The Investigators will use AI to predict patients choice of dialysis. This choice will be recorded by their clinical provider as per normal routine care.
Measured: From August 2024 to August 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Sep 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scaled Insights
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dallas Renal Group, The Leeds Teaching Hospitals NHS Trust, Suffolk and North East Essex NHS Trust
- Responsible party
- Principal investigator, Stuart W. Flint, University of Leeds
- Investigators
- Stuart W Flint, PhD, Principal investigator, Scaled Insights
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533254
- Sponsor's protocol ID
- AI-Dialysis
- Acronym
- AI
- Status last verified
- Nov 2024
- First submitted
- 30 Jul 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flint SW, Brown A, Tahrani AA, Piotrkowicz A, Joseph AC. Cross-sectional analysis to explore the awareness, attitudes and actions of UK adults at high risk of severe illness from COVID-19. BMJ Open. 2020 Dec 29;10(12):e045309. doi: 10.1136/bmjopen-2020-045309.
PubMed 33376185Flint SW, Leaver M, Griffiths A, Kaykanloo M. Disparate healthcare experiences of people living with overweight or obesity in England. EClinicalMedicine. 2021 Sep 15;41:101140. doi: 10.1016/j.eclinm.2021.101140. eCollection 2021 Nov.
PubMed 34585130
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Behavioral Artificial Intelligence to Predict and Increase Uptake of Peritoneal Dialysis [AI-Dialysis]
- ClinicalTrials.gov ID
- NCT06533254
- Acronym / sponsor ID
- AI / AI-Dialysis
- Conditions
- Chronic Kidney Disease
- Keywords
- Chronic Kidney Disease, Artificial Intelligence, Dialysis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Scaled InsightsIndustry (pharma, biotech, devices)
- Collaborators
- Dallas Renal Group, The Leeds Teaching Hospitals NHS Trust, Suffolk and North East Essex NHS Trust
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 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.
Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis
Scaled Insights' can utilize the data from this study to develop individualized nudges for healthcare professionals that can be broadly deployed within a digital platform so that clinics across the English speaking world can use it as a means of supporting patients with CKD in selecting peritoneal dialysis treatment.
Using Scaled Insights novel Behavioral Artificial Intelligence solution, the proposed project has two aims:
- to identify personality attributes of patients with Chronic Kidney Disease and correlating their personality attributes with their subsequent choice of dialysis. Once correlated into personality based clusters, the AI Model will then be able will determine which personality cluster each net new patient will fall into and therefore predict their specific likelihood of opting for peritoneal dialysis or hemodialysis
- once prediction is possible, customized nudges towards the selection of PD will be developed and tested to improve the likelihood that patients will opt for peritoneal dialysis
Hypotheses:
- Scaled Insights Behavioral AI will identify the personality characteristics of patients with Chronic Kidney Disease who are likely to opt for both peritoneal dialysis and hemodialysis (Phase 1)
- Scaled Insights Behavioral AI will identify the nudges that are most effective in encouraging or supporting patients with Chronic Kidney Disease in choosing peritoneal dialysis over hemodialysis (Phase 2)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients who have Chronic Kidney Disease (Phase 1) | – | Other: Predicting choice of dialysisPatients who have Chronic Kidney Disease attending clinics managed by Dallas Renal Group in Texas USA, Leeds Teaching Hospitals NHS Trust UK and Suffolk and North East Essex NHS Trust UK will be contacted via their health care provider to invite them to participate. |
| Patients who have Chronic Kidney Disease (Phase 2) | – | Behavioral: Behavioral nudgesPatients who have Chronic Kidney Disease and are attending the units managed by Dallas Renal Group in Texas USA, Leeds Teaching Hospitals NHS Trust UK and Suffolk and North East Essex NHS Trust UK. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are two phases in this study. Phase 1: 2000 participants in total. 1000 in the USA, and 1000 in the UK; 500 patients who predict they will choose peritoneal dialysis and 500 who predict they will choose hemodialysis in each country. Patients who agree to participate in the study, will consent using an online survey disseminated to patients with Chronic Kidney Disease stage 4-5. Where needed, participants can be supported to complete the survey by a Research Nurse/Assistant to complete the survey. Phase 2: 1000 Patients with Chronic Kidney Disease in total. 500 in the USA and 500 in the UK. Patients who agree to participate in the study. They will be asked to access a link to an online web platform where the study will be hosted.
Key inclusion criteria (2 listed)
- Phase 1: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.
- Phase 2: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.
Key exclusion criteria (2 listed)
- Phase 1: Young people aged \<18 years. People who do not have Chronic Kidney Disease. People who reside outside of the USA and UK.
- Phases 2: Young people aged \<18 years. People who do not have Chronic Kidney Disease stage 4-5. People who reside outside of the USA and UK.
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 |
|---|---|---|
| Predicting choice of dialysisLanguage data collected using survey 1, will be analyzed using Scaled Insights Behavioral AI solution to identify personality attributes and values. The resulting individual scores will be plotted on a graph and be used to identify specific personality clusters of patients. Participants will respond to a survey that utilizes open and closed ended questions, asking broad questions about kidney failure and associated behaviors (e.g. diet, attitudes towards treatment). The open-ended questions will gather a natural language sample of 100-300 words whilst closed questions will capture data using Likert scale and multiple-choice responses. The open-ended questions will gather a natural language sample of 100-300 words for analysis using Scaled Insights Behavioral AI approach. This language sample will be analyzed using Scaled Insights Behavioral AI system to identify personality attributes and values. Patients will also be asked their likelihood of selecting PD over HD. | Other | Patients who have Chronic Kidney Disease (Phase 1) |
| Behavioral nudgesPatients with Chronic Kidney Disease, participants will be provided with their predicted personalized nudge to increase their likelihood of either maintaining their choice of peritoneal dialysis, or switching from hemodialysis to peritoneal dialysis. Participants will respond to a survey that utilizes open and closed ended questions, asking broad questions about kidney failure and associated behaviors (e.g. diet, attitudes towards treatment). The open-ended questions will gather a natural language sample of 100-300 words whilst closed questions will capture data using Likert scale and multiple-choice responses. | Behavioural | Patients who have Chronic Kidney Disease (Phase 2) |
Primary outcome
Choice of Dyalysis
Time frame: From August 2024 to August 2025
The Investigators will use AI to predict patients choice of dialysis. This choice will be recorded by their clinical provider as per normal routine care.
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 2 Dec 2024.
- Results publication: PubMed 33376185Flint SW, Brown A, Tahrani AA, Piotrkowicz A, Joseph AC. Cross-sectional analysis to explore the awareness, attitudes and actions of UK adults at high risk of severe illness from COVID-19. BMJ Open. 2020 Dec 29;10(12):e045309. doi: 10.1136/bmjopen-2020-045309.
- Results publication: PubMed 34585130Flint SW, Leaver M, Griffiths A, Kaykanloo M. Disparate healthcare experiences of people living with overweight or obesity in England. EClinicalMedicine. 2021 Sep 15;41:101140. doi: 10.1016/j.eclinm.2021.101140. eCollection 2021 Nov.
- Website for the AI company that developed the AI solution that will be used in this study.Link provided by the sponsor.
- 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.
Stuart W Flint, PhD principal investigator
Scaled Insights
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Scaled Insights at 1 site 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Stuart W Flint, PhD (+44 7929404094, sflint@scaledinsights.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice of Dyalysis (time frame: From August 2024 to August 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533254, which also lists 2 linked publications.
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 2 Dec 2024.