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

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: mHealth Tool

• Registration Number: NCT03067779
• Lead Sponsor: Duke University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-24
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Study Start: 2017-06-26
• Primary Completion: 2018-07-30
• Study Completion: 2018-07-30
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-08
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Survey and mHealth Tool	mHealth Tool	A survey has been designed that evaluates CRIC participants' computer and mobile phone usage, and perceived e-health literacy. There is also a mobile health-based (mHealth) patient safety educational curriculum that evaluates CRIC participants' knowledge of patient safety hazards in CKD. The mHealth patient safety curriculum tool is also known as eCRIC.

Primary Outcome Measures

Name	Time	Method
Medication Errors	10 minutes	eHealth Literacy questionnaire and how that relates to medication errors
e-literacy questionnaire	10 minutes	eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy

Secondary Outcome Measures

Name	Time	Method
Patient Safety Risk	20 minutes	mHealth tool and how that relates to patient safety risk

Trial Locations

Locations (4)

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, United States