[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100464632":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":19,"centralContacts":31,"locations":37,"responsibleParty":57,"collaborators":61,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":19,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":71,"minAge":72,"maxAge":19,"enrollmentInfo":73,"targetDuration":19,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":40,"whyStopped":19,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Henry Ford Health System","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group","EXPERIMENTAL","PAL2 Intervention\n\nDrug Therapy",[13,14],"Behavioral: PAL2","Drug: PHARM-PAL2",{"label":16,"type":17,"description":18,"interventionNames":19},"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.",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"BEHAVIORAL","PAL2","Community health worked based intervention to mitigate psychosocial and life circumstance barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education Other Names: Pragmatic personalized, adaptable approach to lifestyle and life circumstance",[9],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":19},"DRUG","PHARM-PAL2","All intervention arm participants will be referred to our study pharmacist who will prescribe a antihypertensive medication as per standard of care medical treatment algorithm to achieve BP control.\n\nPer AHA recommended guidelines, participants with an indication of diabetes mellitus (DM) and\u002For CKD will be started on SGLT2 inhibitor within the first month of starting the study intervention.",[9],[32],{"name":33,"role":34,"phone":35,"phoneExt":19,"email":36},"Whitney Cabral, MS","CONTACT","313-874-1887","wcabral1@hfhs.org",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Wayne State University","RECRUITING","Detroit","Michigan","48201","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-83.04575,42.33143,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":19,"email":56},"Paul Kurian","(313) 448-9817","paul.kurian@wayne.edu",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","David Lanfear","Section Head - Advanced Heart Failure and Transplant Cardiology",[62],{"name":39,"class":6},"100464632","project-2-achieve--hf-100464632",false,"NCT05330221","Project 2: ACHIEVE- HF","ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early PreVEntion in the GREAT LakEs Region","Inclusion:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Detroit-area resident (defined as those who attended a Detroit-area community event)\n2. ≥18 years of age\n3. At least one of the following:\n\nA) Screening systolic BP ≥ 140 and\u002For diastolic BP ≥ 90 mm Hg OR\n\nB) Screening BP 130-139 mm Hg plus ≥1 additional HF risk factors:\n\ni. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL\u002Fmin\u002Fm2) OR C) Treated (1-2 antihypertensive medications) stage 1 HTN (systolic BP 130-139 and\u002For diastolic BP 80-89) with or without \\>1 additional HF risk factors OR\n\nD) Treated stage 1 HTN w\u002F systolic BP 120-129 with additional HF risk factors:\n\ni. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL\u002Fmin\u002Fm2)\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Previous diagnosis of HF\n2. Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)\n3. Chronic use of insulin or \\>1 anti-diabetic medication\n4. Self-reported pregnancy (or planning to become pregnant in the next year)\n5. Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and\u002For diastolic BP ≥110 mmHg)\n6. Point of care (POC) BNP measurement ≥400 ng\u002FL. If POC BNP was not obtained, then NTproBNP ≥ 1000 ng\u002FL from screening labs will be excluded.\n7. eGFR \\\u003C45 ml\u002Fmin\u002Fsq-m on SOC screening labs",true,"ALL","18 Years",{"count":74,"type":75},364,"ESTIMATED","INTERVENTIONAL",[78],"NA","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.",[81,82],"Heart Failure","Hypertension",[84,81],"Prevention","2026-07-02",{"date":87,"type":88},"2026-07-07","ACTUAL",{"date":90,"type":88},"2023-01-18",{"date":92,"type":75},"2027-06-30",{"name":5,"class":6},1]