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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03067779
Other study ID # Pro00057833
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


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
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