NCT03067779

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
580

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 1, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

1.1 years

First QC Date

February 24, 2017

Last Update Submit

October 8, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Medication Errors

    eHealth Literacy questionnaire and how that relates to medication errors

    10 minutes

  • e-literacy questionnaire

    eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy

    10 minutes

Secondary Outcomes (1)

  • Patient Safety Risk

    20 minutes

Study Arms (1)

Survey and mHealth Tool

OTHER

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

Interventions

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.

Survey and mHealth Tool

Eligibility Criteria

Age45 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21207, United States

Location

Duke University School of Medicine

Durham, North Carolina, 27701, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clarissa J Diamantidis, MD, MHS

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 24, 2017

First Posted

March 1, 2017

Study Start

June 26, 2017

Primary Completion

July 30, 2018

Study Completion

July 30, 2018

Last Updated

October 9, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

The research team will not be sharing IPD with other researchers.

Locations