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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth Tool
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease

Eligibility Criteria

45 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University of Maryland, Baltimore
  • Johns Hopkins University
  • Duke University School of Medicine
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Survey and mHealth Tool

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Patient Safety Risk
mHealth tool and how that relates to patient safety risk

Full Information

First Posted
February 24, 2017
Last Updated
October 8, 2018
Sponsor
Duke University
Collaborators
University of Pennsylvania, University of Maryland, University of Illinois at Chicago, Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03067779
Brief Title
Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Acronym
eCRIC
Official Title
Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
University of Pennsylvania, University of Maryland, University of Illinois at Chicago, Johns Hopkins University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
580 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Survey and mHealth Tool
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
mHealth Tool
Intervention Description
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 Outcome Measure Information:
Title
Medication Errors
Description
eHealth Literacy questionnaire and how that relates to medication errors
Time Frame
10 minutes
Title
e-literacy questionnaire
Description
eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Patient Safety Risk
Description
mHealth tool and how that relates to patient safety risk
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study. Exclusion Criteria: Not enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clarissa J Diamantidis, MD, MHS
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21207
Country
United States
Facility Name
Duke University School of Medicine
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27701
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The research team will not be sharing IPD with other researchers.

Learn more about this trial

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

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