Preventing Ischemic Heart Disease With mHealth (Mobile Health), Electronic Decision Support and Community Health Workers
NCT05511701
Summary
This is a cluster-randomized clinical trial (cRCT) designed to assess the effectiveness of a multicomponent strategy linking key aspects of the cardiovascular disease (CVD) care continuum across three provinces in Argentina using using five primary components: a data management system linking a digital mHealth (mobile health) screening tool used by community health workers (CHWs), an electronic appointment scheduler which is integrated with the clinic electronic appointment system, point of care (POCT) testing for lipids, a clinical decision support system for medication initiation, and a text message (SMS) reminder system to improve treatment adherence and life-style changes.
Eligibility
Inclusion Criteria: * aged 40-74 * depend exclusively on public health insurance * have access to a cell phone for personal use * can open and read SMS messages on cell phone * receive primary care at the local PCC * have a 10-year CVD risk \>= 10% and mean SBP \>= 140 mmHg OR * have a 10-year CVD risk \>= 10% and LDL-C \>= 70 mg/dL for persons with diabetes OR * have a 10-year CVD risk \>= 10% and LDL-C \>= 100 mg/dL for persons without diabetes Exclusion Criteria: * Persons who plan to move from the neighborhood within the next 2 years * pregnant at the time of screening * Bed bound * Weight \> 180 kg - this exceeds the upper limit that can be measured on portable scales. * Total cholesterol \< 100 mg/dL or \> 500 mg/dL. * LDL-C \> 300 mg/dL * Triglycerides \< 45 mg/dL or \> 400 mg/dL. * HDL \< 15 mg/dL. * Systolic blood pressure (SBP) \>=180 mmHg or Diastolic blood pressure (DBP) \>= 120 mmHg, and experiencing chest pain, palpitations, or shortness of breath. * currently on dialysis or has a history of chronic kidney disease. * self-reported history of CVD (stroke, AMI). * self-reported history of a liver abnormality. * have a mid-upper arm circumference \> 42 cm - this is the maximum cuff size available for use with blood pressure monitors in Argentina * do not consent to participate.
Conditions2
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT05511701