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OpenTrials
Completed

NCT Number: NCT03067779

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

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.

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Key information

Age range

45 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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:

  • 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.

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

mHealth tool

Other

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.

Primary outcomes

  1. Medication Errors

    Time frame: 10 minutes

    eHealth Literacy questionnaire and how that relates to medication errors

  2. e-literacy questionnaire

    Time frame: 10 minutes

    eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy

Secondary outcomes

  1. Patient Safety Risk

    Time frame: 20 minutes

    mHealth tool and how that relates to patient safety risk

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Johns Hopkins University
  • University of Illinois at Chicago
  • University of Maryland
  • University of Pennsylvania

Registry information

Acronym: eCRIC

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 1, 2017
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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