[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05918380":3,"trial-entities:NCT05918380":90,"trial-summary:NCT05918380":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":45,"secondary_outcomes":50,"sex":64,"minimum_age":65,"maximum_age":66,"healthy_volunteers":15,"eligibility_criteria":67,"std_ages":71,"locations":74,"central_contacts":83,"overall_officials":84,"references":88,"see_also_links":89},"NCT05918380","STUDY20220763","Project 3: ACHIEVE- CHD","ACHIEVE GREATER: Addressing Cardiometabolic Health In Populations Through Early Prevention in the Great Lakes Region","ACTIVE_NOT_RECRUITING","2027-01-01","2026-08","2026-08-28","2022-08-15","University Hospitals Cleveland Medical Center","OTHER",false,"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 and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three 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, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will 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 3 of the ACHIEVE GREATER Center.",null,[19],"Coronary Heart Disease",[21,22,23,19],"Health Disparities","African American","Prevention","INTERVENTIONAL","PREVENTION",[27],"NA",{"count":29,"type":30},500,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"BEHAVIORAL","PAL2","Low CVD risk participants (CAC \\\u003C 100) will be followed by their primary care provider accompanied by monthly contact with community health workers provided by ACHIEVE Greater who will screen participants for social determinants of health and implement the PAL2.\n\nPAL2 is defined as a community health worked based intervention to mitigate psychosocial and health equity barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education.",[37],"Low CVD risk",[39],"Pragmatic personalized, adaptable approach to lifestyle and life circumstance",{"type":14,"name":41,"description":42,"armGroupLabels":43},"CINEMA","High CVD risk participants (CAC ≥ 100) will be followed by specialists in the Center for Integrated and Novel Approaches in Vascular-Metabolic Disease (CINEMA) at UHCMC. While they too will be assessed, by the CHW for SDOH and a plan developed to address them, this plan will be addressed by the usual resources available in the CINEMA clinic.",[44],"High CVD risk",[46],{"measure":47,"description":48,"timeFrame":49},"Triple Goal","Percent reaching triple goal of BP \\\u003C130\u002F80 mm Hg, HbA1c\\\u003C5.7% and LDL-C \\\u003C130 mg\u002Fdl (\\\u003C100 if high-risk)","12 months",[51,55,58,61],{"measure":52,"description":53,"timeFrame":54},"Change in HbA1c as measured by blood work","Percent change in HbA1c","baseline, 12 months",{"measure":56,"description":57,"timeFrame":54},"Change in LDL-C as measured by blood work","Percent change in LDL-C",{"measure":59,"description":60,"timeFrame":54},"Change in blood pressure","Percent change in blood pressure",{"measure":62,"description":63,"timeFrame":54},"Change in weight","Percent change in weight","ALL","40 Years","75 Years",{"inclusion":68,"exclusion":69,"raw_text":70},[],[],"Inclusion Criteria:\n\n1. 40 to 75 years of age\n2. Self-identified as Black or African American\n3. Residence in the Cleveland Metro Area\n4. Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL:\n\n   1. BMI≥30 mg\u002FdL\n   2. History of smoking\n   3. Elevated blood pressure defined as SBP\\>140 or DBP\\>80 mmHg\n   4. HbA1c≥5.7%\n   5. LDL≥130\n5. Able to complete a coronary artery calcium score test (CAC)\n6. Willing and able to consent\n7. Willing to have a UH provider and UH care\n8. Currently insured for standard of care procedures\n\nExclusion Criteria:\n\n1. Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).\n2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg\n3. Lung disease requiring supplemental oxygen therapy\n4. Individuals receiving treatment for cancer related disease\n5. Pregnant or nursing mothers",[72,73],"ADULT","OLDER_ADULT",[75],{"facility":13,"city":76,"state":77,"zip":78,"country":79,"geoPoint":80},"Cleveland","Ohio","44106","United States",{"lat":81,"lon":82},41.4995,-81.69541,[],[85],{"name":86,"affiliation":13,"role":87},"Sanjay Rajagopalan, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Coronary heart disease",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study with a planned enrollment of 500 participants. It compares two different approaches to managing coronary heart disease.","completed","ACHIEVE-CHD Study for Coronary Heart Disease","This study, called ACHIEVE-CHD, is looking for Black or African American individuals aged 40-75 in the Cleveland Metro Area who have coronary heart disease (CHD) and certain risk factors. The goal is to improve heart health and reduce health differences. Participants will be divided into two groups based on their heart disease risk. Those with lower risk (CAC \u003C 100) will work with community health workers using a program called PAL2. Those with higher risk (CAC ≥ 100) will receive care from specialists at CINEMA. Both groups will have their social needs assessed to help with their health plan. The study aims to see how well these approaches help participants meet a \"Triple Goal\" for their health after 12 months. The current status of this study is unclear, but it plans to enroll 500 participants.","The primary outcome of the study will be measured at 12 months.",135,"Participants will be followed by their primary care provider or specialists, and some will have monthly contact with community health workers. The primary endpoint is measured at 12 months.","Not stated in the trial record.",[34,41],"v2"]