An interventional study of mHealth Tool in Chronic Kidney Disease, sponsored by Duke University. Completed at 4 sites in United States. Open to participants aged 45 Years to 79 Years. Per ClinicalTrials.gov, last updated 2018-10-09.
Sponsored by Duke University · Not applicable, Interventional, and Prevention
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.
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.
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.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 580 is above the median of 74 across 2,229 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Exclusion Criteria:
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
eHealth Literacy questionnaire and how that relates to medication errors
Time frame: 10 minutes
e-literacy questionnaire
eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy
Time frame: 10 minutes
Patient Safety Risk
mHealth tool and how that relates to patient safety risk
Time frame: 20 minutes
Plan to share: No — The research team will not be sharing IPD with other researchers.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →