- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06533254
Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake (AI)
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:
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Stuart W Flint, PhD
- Phone Number: +44 7929404094
- Email: sflint@scaledinsights.com
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75230
- Recruiting
- Dallas Renal Group
-
Contact:
- Veronica Almanza
- Phone Number: 214-697-7187
- Email: valmanza@dallasrenalgroup.com
-
Contact:
- Kim Adams
- Phone Number: 214-697-7187
- Email: kim.adams@dallasrenalgroup.com
-
Contact:
- Irfan Agha, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart W Flint, PhD, Scaled Insights
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-Dialysis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Chronic Kidney Disease
-
3-C Institute for Social DevelopmentUniversity of North Carolina, Chapel HillCompletedChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Pediatric Kidney Disease | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe) | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease, Stage IUnited States
-
Universiti Putra MalaysiaRecruitingChronic Kidney Diseases | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Requiring Chronic DialysisMalaysia
-
National Taiwan University HospitalCompletedChronic Kidney Disease stage4 | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
Centre Hospitalier le MansLe Mans UniversiteWithdrawnFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage3 | Chronic Kidney Failure | Chronic Kidney Disease, Stage 4 (Severe)
-
Centre Hospitalier le MansLe Mans UniversiteRecruitingFatigue | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease stage4 | Chronic Kidney Disease Stage 3BFrance
-
American Academy of Family PhysiciansUniversity of Colorado, Denver; National Institute of Diabetes and Digestive... and other collaboratorsCompletedChronic Kidney Disease | Chronic Renal Insufficiency | Chronic Kidney Insufficiency | Chronic Renal Diseases | Kidney Insufficiency, ChronicUnited States
-
Lund UniversityBaxter Healthcare Corporation; Universidad de CórdobaCompletedEnd Stage Kidney Disease | Chronic Kidney Disease Requiring Chronic DialysisArgentina
-
Centre Hospitalier Saint Joseph Saint Luc de LyonNot yet recruitingKidney Failure, Chronic | Diet Habit | Chronic Kidney Disease stage3 | Chronic Kidney Disease Stage 3B | Chronic Kidney Disease, Stage 3 (Moderate) | Chronic Kidney Disease Stage 3A (Disorder)France
-
Far Eastern Memorial HospitalActive, not recruitingMetabolic Syndrome | Chronic Disease | Chronic Kidney Disease Stage 5 | Chronic Kidney Disease Stage 3 | Chronic Kidney Disease Stage 4 | Chronic Kidney Disease Stage 2 | Chronic Kidney Disease Stage 1Taiwan
-
A.C. AbrahamsCompletedEnd Stage Renal Disease | Chronic Kidney Disease | End Stage Kidney Disease | Chronic Kidney FailureNetherlands
Clinical Trials on Predicting choice of dialysis
-
University Hospital, GhentUniversity GhentCompletedHemodialysis | CoagulationBelgium
-
University of AarhusAarhus University Hospital; Hillerod Hospital, Denmark; Regional Hospital Holstebro and other collaboratorsCompletedChronic Kidney Diseases
-
University Hospital, GhentCompletedHemodialysis Complication | AnticoagulantsBelgium
-
Western University, CanadaDuke UniversityCompletedHealth Behaviour ChangeCanada
-
Sun Yat-sen UniversityRecruitingHepatocellular CarcinomaChina
-
University of Alabama at BirminghamPfizerCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedLiver Cirrhosis | Hepatocellular Carcinoma | Evidence of Liver TransplantationFrance
-
University College DublinUnknown
-
Al-Azhar UniversityRecruiting
-
Yaqrit LtdKing's College Hospital NHS Trust; University College, London; Royal Free Hospital... and other collaboratorsNot yet recruitingLiver Cirrhosis | Acute-on-Chronic Liver Failure (ACLF)