Clinical trial NCT03067779: Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Official title: Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Maryland
name: University of Illinois at Chicago
name: Johns Hopkins University
First posted: 2017-03-01
Enrollment: 580
Sex: ALL
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Medication Errors
timeFrame: 10 minutes
measure: e-literacy questionnaire
timeFrame: 10 minutes
Secondary outcomes:
measure: Patient Safety Risk
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Duke University
name: Clarissa J Diamantidis, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: