- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00523536
Evaluation of a Navigator-Nurse Care Team on the Management of High Blood Pressure and Cardiovascular Disease Risk
Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR): Evaluation of a Navigator-Nurse Care Team on Hypertension and Cardiovascular Disease Risk
연구 개요
상세 설명
This study represents one phase of a large partnership grant with The Colorado Health Outcomes Program of the University of Colorado at Denver Health Sciences Center (UCDHSC) and Denver Health and Hospital Authority (DH). The overarching goal of Latinos Using Cardio Health Actions to Reduce Risk (LUCHAR) is to improve the primary and secondary prevention of cardiovascular disease (CVD) in Hispanics through a comprehensive research program aimed at (1) increasing awareness of CVD risk in the Hispanic community and increasing participation of high risk Hispanics in the health care system, (2) developing more effective models of care delivery for high risk patients in a health system, and (3) identifying markers that will more effectively identify Hispanic patients at high risk of CVD than current approaches based on traditional risk factors.
This trial has been designed to assess the effectiveness of a quality improvement project which focuses on the hypertensive multiracial underserved population within the Denver Health system. In addition, we are hoping at study end to have developed and validate this project as an efficient and sustainable approach to improving blood pressure control and controlling cardiovascular risk factors, especially in the vulnerable patient population served at Denver Health.
The objective of this quality improvement program is to conduct a randomized, primary care-based, efficacy trial evaluating the effectiveness of a patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors using information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews. The study is designed to test the hypothesis that a patient navigator-nurse assisted intervention will improve blood pressure (BP) in vulnerable hypertensive patients, compared with usual clinical care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Colorado
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Denver, Colorado, 미국, 80204
- East Adult Clinic, Denver Health
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Active patients from the Target Adult Health Clinic
- Identified with a diagnosis of hypertension
- Uncontrolled hypertension (2 of 3 last BP measurements above target BP range; target BP is defined at 140/90 or 130/80 mm Hg for people with diabetes or kidney disease)
Exclusion Criteria:
- Pregnant or breastfeeding
- End-stage kidney disease requiring dialysis
- Co-morbid illness with life expectancy less than 12 months
- Institutionalized individuals because of the potentially confounding factors due to severe co-morbidity or other medical conditions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
Patient navigator-nurse disease management intervention
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The patient navigator-nurse disease management intervention for treating hypertension and its associated cardiovascular risk factors will use information obtained in earlier phases of the LUCHAR grant: i.e., algorithms, risk factor profiles, and qualitative data from focus groups and interviews.
The study will test the effect of this intervention on blood pressure control and utilization of hospital services in adult patients with hypertension.
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간섭 없음: 2
Usual clinical care
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Change in SBP level
기간: Measured at Year 1
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Measured at Year 1
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2차 결과 측정
결과 측정 |
기간 |
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Percentage of participants with BP control by JNC-7 guidelines, adherence with BP medications, lipid control, change of HgbA1c for participants with diabetes, and change in smoking status/BMI
기간: Measured at Year 1
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Measured at Year 1
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Utilization of urgent care visits/emergency department/hospitalizations
기간: Measured at Year 1
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Measured at Year 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Raymond O. Estacio, MD, Denver Health, University of Colorado at Denver Health Sciences Center
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
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