Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake (AI)

November 27, 2024 updated by: Stuart W. Flint, Scaled Insights

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.

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)

Study Overview

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From August 2024 to August 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Stuart W Flint, PhD, Scaled Insights

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 30, 2024

First Submitted That Met QC Criteria

July 30, 2024

First Posted (Actual)

August 1, 2024

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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