- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03067779
Is There a Digital Divide in Chronic Kidney Disease (CKD)? (eCRIC)
Studieoversigt
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Maryland
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Baltimore, Maryland, Forenede Stater, 21201
- University of Maryland, Baltimore
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Baltimore, Maryland, Forenede Stater, 21207
- Johns Hopkins University
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North Carolina
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Durham, North Carolina, Forenede Stater, 27701
- Duke University School of Medicine
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.
Exclusion Criteria:
- Not enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Andet: 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. |
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Medication Errors
Tidsramme: 10 minutes
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eHealth Literacy questionnaire and how that relates to medication errors
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10 minutes
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e-literacy questionnaire
Tidsramme: 10 minutes
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eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy
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10 minutes
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Patient Safety Risk
Tidsramme: 20 minutes
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mHealth tool and how that relates to patient safety risk
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20 minutes
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Clarissa J Diamantidis, MD, MHS, Duke University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00057833
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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