[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06364358":3,"trial-entities:NCT06364358":125,"trial-summary:NCT06364358":129},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":55,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":15,"eligibility_criteria":71,"std_ages":86,"locations":89,"central_contacts":111,"overall_officials":116,"references":119,"see_also_links":124},"NCT06364358","IRB23-0385","Interactive Computer-adaptive Chronic Kidney Disease Education Program","A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)","RECRUITING","2026-09","2024-08","2025-01-08","2023-05-31","University of Chicago","OTHER",false,"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","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\u002For 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\u002For 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.",[19,20],"Chronic Kidney Diseases","Hypertension",[22,23,24],"African American","Hospitalized","Patient education","INTERVENTIONAL","HEALTH_SERVICES_RESEARCH",[28],"NA",{"count":30,"type":31},120,"ESTIMATED",[33,39],{"type":34,"name":35,"description":36,"armGroupLabels":37},"BEHAVIORAL","Computerized CKD Education","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.",[38],"Computerized Patient Education",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Usual Hospital Care","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",[43],"Usual Care",[45,49,52],{"measure":46,"description":47,"timeFrame":48},"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","Baseline and 1 day post-intervention",{"measure":50,"description":51,"timeFrame":48},"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",{"measure":53,"description":54,"timeFrame":48},"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.",[56,60,64],{"measure":57,"description":58,"timeFrame":59},"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)","Baseline, 1 day post-intervention, and 30 day follow-up",{"measure":61,"description":62,"timeFrame":63},"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.","Baseline, 1 day post-intervention and 30 day follow-up",{"measure":65,"description":66,"timeFrame":67},"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 \u002Ffalse 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","Baseline and 30 day follow-up","ALL","18 Years","70 Years",{"inclusion":72,"exclusion":77,"raw_text":85},[73,74,75,76],"African-American inpatients","Ages 18-70","estimated glomerular filtration rate (eGFR)\\\u003C45","Enrolled in the Hospitalist Project",[78,79,80,81,82,83,84],"Does not self-identify as African American","Not able to consent","Unable to speak English","eGFR \\\u003C45 due to acute kidney injury","In Intensive Care Unit","has had a transplant","currently on dialysis","Inclusion Criteria:\n\n* African-American inpatients\n* Ages 18-70\n* estimated glomerular filtration rate (eGFR)\\\u003C45\n* Enrolled in the Hospitalist Project\n\nExclusion Criteria:\n\n* Does not self-identify as African American\n* Not able to consent\n* Unable to speak English\n* eGFR \\\u003C45 due to acute kidney injury\n* In Intensive Care Unit\n* has had a transplant\n* currently on dialysis",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":108},"University of Chicago Medical Center","Chicago","Illinois","60637","United States",[97,102,105],{"name":98,"role":99,"phone":100,"email":101},"Milda Saunders, MD","CONTACT","773-702-5941","msaunders@uchicago.edu",{"name":103,"role":99,"email":104},"Akilah King, MSW","Akilah.King@bsd.uchicago.edu",{"name":106,"role":107},"Milda R. Saunders, MD","PRINCIPAL_INVESTIGATOR",{"lat":109,"lon":110},41.85003,-87.65005,[112,115],{"name":98,"role":99,"phone":113,"email":114},"7737025941","msaunder@bsd.uchicago.edu",{"name":103,"role":99,"email":104},[117],{"name":98,"affiliation":118,"role":107},"Associate Professor of Medicine",[120],{"pmid":121,"type":122,"citation":123},"40245387","DERIVED","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\u002F66846.",[],{"nct_id":4,"conditions":126,"biomarkers":128},[127],"Chronic Kidney Disease",[],{"nct_id":4,"found":130,"summary":131,"prompt_version":141},true,{"design":132,"status":133,"heading":134,"summary":135,"follow_up":136,"word_count":137,"commitments":138,"compensation":139,"drugs_mentioned":140},"This interventional study plans to enroll 120 participants. It compares an interactive computer program to usual hospital care.","completed","Interactive Education for Advanced Chronic Kidney Disease","This study is testing an interactive computer program called \"Computerized CKD Education\" to see if it helps African-American patients with advanced chronic kidney disease (CKD) learn more about their condition and treatment options. This program is designed to be culturally specific. Researchers will compare it to standard hospital care, which includes general health education materials. To join, you must be an African-American inpatient between 18 and 70 years old, with an estimated glomerular filtration rate (eGFR) less than 45 (a measure of kidney function) due to chronic kidney disease, and enrolled in the Hospitalist Project. The study aims to see if the computer program improves your knowledge about CKD and your choices for treatment. The study is currently unclear on its recruitment status and plans to enroll 120 people.","Your knowledge and treatment preferences will be measured at the start of the study and one day after the education intervention.",129,"You would participate in an education program and complete surveys at the beginning of the study and one day after the education.","Not stated in the trial record.",[35],"v2"]