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Trial record 10 of 52 for:    Recruiting, Not yet recruiting, Available Studies | "Patient Safety"

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

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ClinicalTrials.gov Identifier: NCT03067779
Recruitment Status : Recruiting
First Posted : March 1, 2017
Last Update Posted : April 2, 2018
Sponsor:
Collaborators:
University of Pennsylvania
University of Maryland
University of Illinois at Chicago
Johns Hopkins University
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Other: mHealth Tool Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Is There a Digital Divide in Chronic Kidney Disease (CKD)?
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : May 30, 2018
Estimated Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Medication Errors [ Time Frame: 10 minutes ]
    eHealth Literacy questionnaire and how that relates to medication errors

  2. e-literacy questionnaire [ Time Frame: 10 minutes ]
    eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy


Secondary Outcome Measures :
  1. Patient Safety Risk [ Time Frame: 20 minutes ]
    mHealth tool and how that relates to patient safety risk



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Clarissa J Diamantidis, MD, MHS (919) 668-1261 clarissa.j.diamantidis@duke.edu
Contact: Nikita Shah, BS (919) 613-6319 nikita.shah@duke.edu

Locations
United States, Maryland
University of Maryland, Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: Wanda Fink, MS, BSN, RN    410-706-6559    WFINK@som.umaryland.edu   
Principal Investigator: Jeffery Fink, MD         
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21207
Contact: Jeanne Charleston    410-281-1600    jeannec@jhmi.edu   
Principal Investigator: Lawrence Appel, MD         
United States, North Carolina
Duke University School of Medicine Active, not recruiting
Durham, North Carolina, United States, 27701
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Angie Sheridan    215-615-4886    angsher@mail.med.upenn.edu   
Principal Investigator: Raymond Townsend, MD         
Sponsors and Collaborators
Duke University
University of Pennsylvania
University of Maryland
University of Illinois at Chicago
Johns Hopkins University
Investigators
Principal Investigator: Clarissa J Diamantidis, MD, MHS Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03067779     History of Changes
Other Study ID Numbers: Pro00057833
First Posted: March 1, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research team will not be sharing IPD with other researchers.

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

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency