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临床试验/NCT05330221
NCT05330221进行中(未招募)不适用

ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region

Henry Ford Health System2 个研究点 分布在 1 个国家目标入组 364 人开始时间: 2023年1月18日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
364
试验地点
2
主要终点
Systolic blood pressure (BP)

研究概览

简要总结

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves four separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Projects 2 and 4) and coronary heart disease (CHD, Project 3). The first three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. Projects 1-3 also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 2 of the ACHIEVE GREATER Center.

详细描述

Heart failure (HF) is one of the most common, costly, and deadly diseases affecting humans. Hypertension is the largest single risk factor for HF, accounting for over half of all new cases. Accordingly, early interventions to prevent HF, in particular blood pressure (BP) control, are critical. However, implementation of effective treatments remains suboptimal, especially in Detroit, Michigan. To better engage the at-risk community, the team developed an innovative mobile health unit (MHU) program that uses geospatial health and area-level exposure data to direct health services to communities in highest need, who may not otherwise engage with traditional health care settings. Another key to preventing HF is usage of guideline-directed medical therapy (GDMT), not only for treating high BP, but also providing medications proven to reduce HF incidence. In particular, inhibitors of sodium-glucose transporter type 2 (SGLT2) prevent HF and loss of kidney function in at-risk patients. Yet, these are dramatically under-utilized, further contributing to health disparities. Project 2 of ACHIEVE GREATER uses a pragmatic, randomized, unblinded, clinical trial to implement and test a novel intervention leveraging our MHU platform to improve care access combined with enhanced collaborative care delivery among patients with Stage A HF (defined as asymptomatic individuals with known pre-conditions such as hypertension who are at-risk for later-stage clinical HF). The key components of the program are 1) a personalized intervention conducted by community health workers that links patients with available community resources, and 2) pharmacist-directed therapy optimization per a standardized GDMT protocol. This intervention will address multiple domains and levels of impact to reduce the large gaps in care of stage-A HF patients in the community and prevent progression towards symptomatic HF.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Detroit-area resident (defined as those who attended a Detroit-area community event)
  • ≥18 years of age
  • At least one of the following:
  • A) Screening systolic BP ≥ 140 and/or diastolic BP ≥ 90 mm Hg OR
  • B) Screening BP 130-139 mm Hg plus ≥1 additional HF risk factors:
  • i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2) OR C) Treated (1-2 antihypertensive medications) stage 1 HTN (systolic BP 130-139 and/or diastolic BP 80-89) with or without >1 additional HF risk factors OR
  • D) Treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors:
  • i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2)

排除标准

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Previous diagnosis of HF
  • Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
  • Chronic use of insulin or >1 anti-diabetic medication
  • Self-reported pregnancy (or planning to become pregnant in the next year)
  • Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP ≥110 mmHg)
  • Point of care (POC) BNP measurement ≥400 ng/L. If POC BNP was not obtained, then NTproBNP ≥ 1000 ng/L from screening labs will be excluded.
  • eGFR <45 ml/min/sq-m on SOC screening labs

研究组 & 干预措施

Intervention Group

Experimental

PAL2 Intervention

Drug Therapy

干预措施: PHARM-PAL2 (Drug)

Intervention Group

Experimental

PAL2 Intervention

Drug Therapy

干预措施: PAL2 (Behavioral)

Usual Care Group

No Intervention

Participants that are randomized into usual care will be assisted with arrangement of follow-up, either with existing primary care provider (PCP) or a Wayne Health provider. All subsequent medical treatment will be at the discretion of the PCP.

结局指标

主要结局

Systolic blood pressure (BP)

时间窗: 12 months

Change in systolic BP at 12-months vs. baseline (detect ≥ 5 mm Hg difference). This will be determined by comparing the "post-trial systolic BP" at 12-month mobile health unit (MHU) visit versus the "baseline systolic BP" at screening MHU visit.

NT-proB-type Natriuretic Peptide (NT-proBNP)

时间窗: 12 months

Change in NT-proBNP over 12 months

次要结局

  • Utilization rates for anti-RAS medications and SGLT2 inhibitors(12 months)
  • Geospatial outreach(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Lanfear

Section Head - Advanced Heart Failure and Transplant Cardiology

Henry Ford Health System

研究点 (2)

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