ClinicalTrials.gg
RecruitingNCT06533254AIUpdated Dec 2, 2024

Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake

An observational study in Chronic Kidney Disease, sponsored by Scaled Insights. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-02.

Sponsored by Scaled Insights · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Study 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 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:

  1. 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
  2. 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:

  1. 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)
  2. 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)
02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Chronic Kidney Disease
  • Artificial Intelligence
  • Dialysis
03

In context

Renal Insufficiency, Chronic

3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

This is the only study on the registry with Scaled Insights as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Behavioral: Behavioral nudges

Interventions

  • OtherPredicting choice of dialysis

    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.

  • BehavioralBehavioral nudges

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From August 2024 to August 2025

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 33376185 ↗
  • Flint 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Aug 2025, 11 months after the start.

Of 57 industry-sponsored observational studies under Renal Insufficiency, Chronic, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 41. This study's planned 11 months is below that.

Counting every sponsor, half of 345 studies reached it within 40 months; a quarter within 20 and three quarters within 128.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2024
First posted
Aug 1, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Aug 31, 2025
CompletionEst.
Dec 31, 2025
Last update
Dec 2, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 2, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533254
Lead sponsor
Scaled Insights
Collaborators
Dallas Renal Group, The Leeds Teaching Hospitals NHS Trust, Suffolk and North East Essex NHS Trust
Responsible party
Stuart W. Flint (Dr Stuart W. Flint, University of Leeds) — Principal investigator
First posted
Aug 1, 2024
Start date
Sep 1, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Dec 2, 2024

Study contacts

Stuart W Flint, PhD
Contact
sflint@scaledinsights.com
+44 7929404094
Stuart W Flint, PhD
principal investigator · Scaled Insights

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion