- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03067779
Is There a Digital Divide in Chronic Kidney Disease (CKD)? (eCRIC)
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Maryland
-
Baltimore, Maryland, 미국, 21201
- University of Maryland, Baltimore
-
Baltimore, Maryland, 미국, 21207
- Johns Hopkins University
-
-
North Carolina
-
Durham, North Carolina, 미국, 27701
- Duke University School of Medicine
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, 미국, 19104
- University of Pennsylvania
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.
Exclusion Criteria:
- Not enrolled in Chronic Renal Insufficiency Cohort (CRIC) Study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Medication Errors
기간: 10 minutes
|
eHealth Literacy questionnaire and how that relates to medication errors
|
10 minutes
|
|
e-literacy questionnaire
기간: 10 minutes
|
eHEALS portion of the questionnaire will be used to determine eHealth literacy and e-literacy
|
10 minutes
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patient Safety Risk
기간: 20 minutes
|
mHealth tool and how that relates to patient safety risk
|
20 minutes
|
공동 작업자 및 조사자
스폰서
협력자
수사관
- 수석 연구원: Clarissa J Diamantidis, MD, MHS, Duke University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
만성 신장 질환에 대한 임상 시험
-
Hospital Clinic of BarcelonaAstraZeneca완전한CTO(Chronic Total Occlusion)를 위한 PCI(Percutaneous Coronary Intervention)를 받을 예정인 환자스페인
-
University Hospital, Basel, Switzerland아직 모집하지 않음
-
L2 Bio, LLCFDAMap; Akan Biosciences, Inc.아직 모집하지 않음Crohn & amp;#39; s | Crohn & amp;#39; s Disease (CD)
-
Vanderbilt University Medical CenterTakeda Pharmaceuticals U.S.A., Inc.모집하지 않고 적극적으로염증성 장질환(IBD) | 궤양성 대장염(UC) | Crohn & amp;#39; s Disease (CD)미국
-
Nandakumar NarayananNational Institute of Neurological Disorders and Stroke (NINDS)초대로 등록
-
UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of Health모집하지 않고 적극적으로
-
Novartis Pharmaceuticals모병류마티스 관절염 (RA) 및 Sjögren 's Disease (SJD)스페인, 프랑스, 독일, 싱가포르
mHealth Tool에 대한 임상 시험
-
Necmettin Erbakan UniversityKonya City Hospital모병
-
The University of Texas Health Science Center at...완전한
-
University of SevilleUniversity of Technology Munich모병
-
Trakya University완전한치료 준수 | 자가 관리 | 급성 심근 경색증(AMI) | Lifte의 품질 | 모바일 건강 기술(mHealth)칠면조
-
University of ConnecticutNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)완전한
-
Hiroshima UniversityNorth South University, Bangladesh아직 모집하지 않음
-
Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI); Ohio University모병흑색종 | 유방암 | 다발성 골수종 | 폐암 | 전립선암미국
-
NYU Langone HealthNational Institutes of Health (NIH)완전한