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临床试验/NCT06364358
NCT06364358招募中不适用

A Pilot to Develop and Test an Interactive Computer-adaptive Chronic Kidney Disease Education Program for Hospitalized African American Patients (I-C-CKD)

University of Chicago1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年5月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •African-American inpatients
  • •Ages 18-70
  • •estimated glomerular filtration rate (eGFR)<45
  • •Enrolled in the Hospitalist Project

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Usual Hospital Care (Behavioral)

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.

干预措施: Computerized CKD Education (Behavioral)

结局指标

主要结局

Change in Knowledge about end stage kidney disease (ESKD) treatments from baseline to 1 day post patient education intervention

时间窗: 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 CKD Knowledge baseline to post patient education intervention

时间窗: 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 ESKD Treatment Preferences from baseline to 1 day post-intervention

时间窗: 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.

次要结局

  • Change in Patient Activation Measure from Baseline to 30 days Post-intervention(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)(Baseline, 1 day post-intervention and 30 day follow-up)
  • CKD Self-Management from baseline to 30 day post-intervention(Baseline and 30 day follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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