Is There a Digital Divide in Chronic Kidney Disease (CKD)? (eCRIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03067779|
Recruitment Status : Active, not recruiting
First Posted : March 1, 2017
Last Update Posted : July 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Other: mHealth Tool||Not Applicable|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Is There a Digital Divide in Chronic Kidney Disease (CKD)?|
|Actual Study Start Date :||June 26, 2017|
|Estimated Primary Completion Date :||July 30, 2018|
|Estimated Study Completion Date :||July 30, 2018|
Survey and 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.
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.
- Medication Errors [ Time Frame: 10 minutes ]eHealth Literacy questionnaire and how that relates to medication errors
- e-literacy questionnaire [ Time Frame: 10 minutes ]eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy
- Patient Safety Risk [ Time Frame: 20 minutes ]mHealth tool and how that relates to patient safety risk
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03067779
|United States, Maryland|
|University of Maryland, Baltimore|
|Baltimore, Maryland, United States, 21201|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21207|
|United States, North Carolina|
|Duke University School of Medicine|
|Durham, North Carolina, United States, 27701|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Clarissa J Diamantidis, MD, MHS||Duke University|