Is There a Digital Divide in Chronic Kidney Disease (CKD)?

Chronic Kidney Disease Clinical Trial

— eCRIC  

Official title:

Is There a Digital Divide in Chronic Kidney Disease (CKD)?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067779
• Other study ID #: Pro00057833
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: July 30, 2018

Study information

• Verified date: October 2018
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is looking to improve the safety of patients with chronic kidney disease via education provided on a mobile tablet. This study will additionally examine if electronic tools, such as mobile tablets, can help.

Description:

Individuals with CKD are at risk for adverse safety events, yet little is known regarding the utility of health information technology (IT) educational tools to reduce these events. The results of this project will be invaluable in gaining a better understanding of the limitations and potential for use of a patient-centered mHealth patient safety educational intervention in high-risk individuals with CKD.

The study will evaluate the perceived eHealth literacy of patients with CKD and its relation to medication errors in the CRIC cohort. The hypothesis is that a novel mHealth-based patient safety curriculum designed to address a wide-range of e-literacy will be effective in attenuating the identified Digital Divide adversely affecting many CKD patients, and will reduce adverse safety events common in this population.

Study Aims:

1. Examine the association between surveyed perceived e-literacy and medication errors in individuals with CKD

Hypothesis 1: Medication error rates will be higher among CRIC participants with low eHealth literacy.

2. Assess the acceptance and feasibility of a novel mHealth-based patient safety curriculum to improve patient safety risk knowledge among individuals with CKD and determine its efficacy in increasing patient safety risk awareness.

Hypothesis 2a: A low literacy mHealth patient safety curriculum will improve patient safety risk awareness among high risk individuals with CKD.

Hypothesis 2b: Medication error rates will be higher among CRIC participants with low patient safety risk awareness.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 580
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 79 Years

Eligibility

Inclusion Criteria:

• Enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.

Exclusion Criteria:

• Not enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• mHealth Tool
The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing common patient safety themes in CKD and includes a pre- and post-test knowledge assessment. Topics of emphasis included NSAID risk awareness, hypoglycemia awareness, avoidance of volume depletion when ill ("Sick Day Protocol") and avoidance of contrast-induced nephropathy.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Duke University School of Medicine	Durham	North Carolina
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Johns Hopkins University, University of Illinois at Chicago, University of Maryland, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Errors	eHealth Literacy questionnaire and how that relates to medication errors	10 minutes
Primary	e-literacy questionnaire	eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy	10 minutes
Secondary	Patient Safety Risk	mHealth tool and how that relates to patient safety risk	20 minutes