Chronic Kidney DiseasesICCKDNCT06364358
Interactive Computer-adaptive Chronic Kidney Disease Education Program
A study testing Computerized CKD Education and Usual Hospital Care in people with Chronic Kidney Diseases and Hypertension, run by University of Chicago at 1 site in United States.
Trial summary
The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- What is being tested?
- Computerized CKD Education and Usual Hospital Care
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- African-American inpatients
- Ages 18-70
- estimated glomerular filtration rate (eGFR)<45
- Enrolled in the Hospitalist Project
Who cannot join
- Does not self-identify as African American
- Not able to consent
- Unable to speak English
- eGFR <45 due to acute kidney injury
- In Intensive Care Unit
- has had a transplant
- currently on dialysis
Trial locations and contacts
1 site in 1 country.
Akilah King, MSW contact
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Milda Saunders, MD, 773-702-5941, msaunders@uchicago.edu
Akilah King, MSW, Akilah.King@bsd.uchicago.edu
About this study
Official title: A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)
The goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC
Read the detailed description
The goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The investigator's first hypothesis is that computerized adaptive education (CAE) will be more effective than standard of care in improving knowledge about self-care for advanced CKD and renal replacement therapy (RRT) options (Primary Outcome). The primary outcome is knowledge about CKD and knowledge about RRT. The study team will measure this using the Kidney Disease Knowledge Survey (KiKs). The investigator's second hypothesis is that CAE will increase patients' intent to participate in CKD self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey and measure patient activation through the Patient Activation Measure (PAM). Similarly, the investigator hypothesizes that CAE will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (PD) or home hemodialysis (HHD), and/or have transplant evaluation compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey. The investigator's final hypothesis is that CAE will increase patients' action at 30 days post-discharge in participating in CKD self-care and CKD health-seeking behavior compared to standard of care controls.
- Conditions
- Chronic Kidney Diseases, Hypertension
- Being tested
- Computerized CKD Education, Usual Hospital Care
- Keywords
- African American, Hospitalized, Patient education
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized CKD EducationBehavioural
The intervention is a culturally tailored computer-based adaptive program (developed during this intervention) to educate patients about kidney disease and renal replacement therapy options.
Usual Hospital CareBehavioural
Computer based patient education materials about general healthy lifestyle that will include information about the importance of a healthy diet, physical activity and medical adherence
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | The research assistant (RA) will use tablet to give participants baseline General Health Knowledge and Intent survey and leave printed patient education materials about general health maintenance. In the initial consent, pre-intervention survey and education materials, investigators will not provide CKD specific knowledge or inform participants about their CKD. Receives: Behavioral: Usual Hospital Care |
| Computerized Patient Education | Experimental | The RA will assist participants in starting the computer program and encourage review of the advanced CKD education module. The computer-adaptive education module will alter the content of education topics based on some preliminary participant information. Receives: Behavioral: Computerized CKD Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CKD Knowledge baseline to post patient education intervention
The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores
Measured: Baseline and 1 day post-intervention
Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention
The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24
Measured: Baseline and 1 day post-intervention
Change in ESKD Treatment Preferences from baseline to 1 day post-intervention
The Kidney Failure Treatment Preferences Survey is an investigator developed tool that assess change in certainty of preference for each of six ESKD treatments. Scores range -12 to 12 with each question scored as -2 extremely unlikely to choose a modality to +2 extremely likely to choose a modality with a change from 0 (in any direction) as an increase in certainty.
Measured: Baseline and 1 day post-intervention
Secondary outcomes (3)
Change in Patient Activation Measure from Baseline to 30 days Post-intervention
The Patient Activation Measure (PAM) is a 10-item questionnaire that assesses an individual´s knowledge, skills, and confidence for managing their health and health care. The measure assesses individuals on a 0-100 scale that converts to one of four levels of activation, from low (1) to high (4). Change =Post intervention score (1 day and 30 day)-baseline score)
Measured: Baseline, 1 day post-intervention, and 30 day follow-up
Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up)
The Health Intent Survey is an investigator-developed tool to measure participants stated intent to make healthy lifestyle changes. There are 10 questions each scored on a 5 point scale from 1=extremely unlikely to 5=extremely likely (50 total possible points with higher scores better). Change=30 day follow-up - baseline and 1 day post-intervention - baseline.
Measured: Baseline, 1 day post-intervention and 30 day follow-up
CKD Self-Management from baseline to 30 day post-intervention
The CKD Self-Management Knowledge Toolkit (CKD-SMKT) is a validated 10 item survey to assess participants CKD self-management behaviors. The survey consists of 2 true /false questions for each of the 10 self-care domains and can be scored from 0 (no self-care) to 20 (full self-care). Change is 30 day score-Baseline
Measured: Baseline and 30 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start31 May 2023
- Primary completionJun 2025 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Milda Saunders, MD, Principal investigator, Associate Professor of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364358
- Sponsor's protocol ID
- IRB23-0385
- Other IDs
- 5R21DK121262
- Acronym
- ICCKD
- Status last verified
- Aug 2024
- First submitted
- 18 May 2023
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Can share individual participant data (IPD) based on researcher data plan and IRB approval
Publications
King A, Omoniyi T, Zasadzinski L, Gaspard C, Gorman D, Saunders M. Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 17;14:e66846. doi: 10.2196/66846.
PubMed 40245387
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)
- ClinicalTrials.gov ID
- NCT06364358
- Acronym / sponsor ID
- ICCKD / IRB23-0385
- Conditions
- Chronic Kidney Diseases, Hypertension
- Keywords
- African American, Hospitalized, Patient education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 31 May 2023 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 15 Apr 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 goal of this pilot clinical trial is to evaluate a culturally tailored computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The main question it aims to answer are: does computerized adaptive education (CAE) increase patients' knowledge about CKD self-care and renal replacement therapy (RRT) options compared to usual care (UC) and will CAE will be increase patients' intent to participate in CKD self-care and RRT preparation compared to UC
Detailed description
The goal of this pilot clinical trial is to evaluate a culturally tailored adaptive computerized education program in hospitalized African-American patients with advanced chronic kidney disease (CKD). The investigator's first hypothesis is that computerized adaptive education (CAE) will be more effective than standard of care in improving knowledge about self-care for advanced CKD and renal replacement therapy (RRT) options (Primary Outcome). The primary outcome is knowledge about CKD and knowledge about RRT. The study team will measure this using the Kidney Disease Knowledge Survey (KiKs). The investigator's second hypothesis is that CAE will increase patients' intent to participate in CKD self-care (to take diabetes and/or hypertension meds, see a nephrologist, and make additional lifestyle changes like smoking cessation, exercise, low-salt diet) compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey and measure patient activation through the Patient Activation Measure (PAM). Similarly, the investigator hypothesizes that CAE will increase patients' intent to obtain non-catheter access prior to dialysis initiation, to initiate self-care dialysis (peritoneal (PD) or home hemodialysis (HHD), and/or have transplant evaluation compared to standard of care. The study team will measure this using an investigator-developed Health Intent Survey. The investigator's final hypothesis is that CAE will increase patients' action at 30 days post-discharge in participating in CKD self-care and CKD health-seeking behavior compared to standard of care controls.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual Hospital CareThe research assistant (RA) will use tablet to give participants baseline General Health Knowledge and Intent survey and leave printed patient education materials about general health maintenance. In the initial consent, pre-intervention survey and education materials, investigators will not provide CKD specific knowledge or inform participants about their CKD. |
| Computerized Patient Education | Experimental | Behavioral: Computerized CKD EducationThe RA will assist participants in starting the computer program and encourage review of the advanced CKD education module. The computer-adaptive education module will alter the content of education topics based on some preliminary participant information. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- African-American inpatients
- Ages 18-70
- estimated glomerular filtration rate (eGFR)<45
- Enrolled in the Hospitalist Project
Key exclusion criteria (7 listed)
- Does not self-identify as African American
- Not able to consent
- Unable to speak English
- eGFR <45 due to acute kidney injury
- In Intensive Care Unit
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 |
|---|---|---|
| Computerized CKD EducationThe intervention is a culturally tailored computer-based adaptive program (developed during this intervention) to educate patients about kidney disease and renal replacement therapy options. | Behavioural | Computerized Patient Education |
| Usual Hospital CareComputer based patient education materials about general healthy lifestyle that will include information about the importance of a healthy diet, physical activity and medical adherence | Behavioural | Usual Care |
Primary outcome
Change in CKD Knowledge baseline to post patient education intervention
Time frame: Baseline and 1 day post-intervention
The Kidney Disease Knowledge Questionnaire (KIKS) is a validated instrument that assesses CKD knowledge. Scores range from 0 (no knowledge)-28 (full knowledge). Change =Post intervention-Baseline scores
Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention
Time frame: Baseline and 1 day post-intervention
The Kidney Failure Treatment Knowledge is an investigator developed tool that assesses knowledge of 6 ESKD treatment options using a Likert scale (0=no knowledge and 4=a great deal of knowledge). Possible scores range from 0-24
Change in ESKD Treatment Preferences from baseline to 1 day post-intervention
Time frame: Baseline and 1 day post-intervention
The Kidney Failure Treatment Preferences Survey is an investigator developed tool that assess change in certainty of preference for each of six ESKD treatments. Scores range -12 to 12 with each question scored as -2 extremely unlikely to choose a modality to +2 extremely likely to choose a modality with a change from 0 (in any direction) as an increase in certainty.
3 secondary outcomes
Change in Patient Activation Measure from Baseline to 30 days Post-intervention
Time frame: Baseline, 1 day post-intervention, and 30 day follow-up
Increase in Health Intent baseline to post intervention (at 1 day and 30 day follow-up)
Time frame: Baseline, 1 day post-intervention and 30 day follow-up
CKD Self-Management from baseline to 30 day post-intervention
Time frame: Baseline and 30 day follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
- Derived from this study: PubMed 40245387King A, Omoniyi T, Zasadzinski L, Gaspard C, Gorman D, Saunders M. Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) Education for Hospitalized African American Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Apr 17;14:e66846. doi: 10.2196/66846.
- Individual participant dataSharing planned: Yes. Can share individual participant data (IPD) based on researcher data plan and IRB approval
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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.
Akilah King, MSW contact
Milda Saunders, MD principal investigator
Associate Professor of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized CKD Education and Usual Hospital Care in people with Chronic Kidney Diseases and Hypertension, run by University of Chicago 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 8 Jan 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Milda Saunders, MD (7737025941, msaunder@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CKD Knowledge baseline to post patient education intervention (time frame: Baseline and 1 day post-intervention). The study lists 3 primary outcomes in all. 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 NCT06364358, which also lists 1 linked publication.
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 8 Jan 2025.