Using mobile health tools to prevent heart disease in Argentina

Preventing Ischemic Heart Disease With mHealth, Electronic Decision Support, and Community Health Workers (PRIMECare Trial)

This study is testing a new way to help people in Argentina who are at high risk for heart disease by using mobile health tools and support to see if it can lower their chances of developing heart problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 954 (estimated)
• Ages: 40 Years to 74 Years
• Sex: All
• Sponsor: Harvard School of Public Health (HSPH) (Academic / other)
• Locations: 1 site (Buenos Aires)
• Trial ID: NCT05511701 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a multicomponent strategy aimed at reducing cardiovascular disease (CVD) risk among high-risk individuals in Argentina. It involves a cluster-randomized design where 18 primary care clinics will either provide usual care or an enhanced intervention that includes mobile health screening, electronic appointment scheduling, point of care testing for lipids, clinical decision support for medication, and SMS reminders for adherence. The study will recruit 954 participants aged 40-74 who are at high risk for CVD, with the primary outcome being the mean difference in absolute 10-year CVD risk over a 12-month period.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 40-74 with a 10-year CVD risk of 10% or higher who have access to public health insurance and a personal cell phone.

Not a fit: Patients who are pregnant, bed bound, or have severe cardiovascular conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of ischemic heart disease among high-risk populations in Argentina.

How similar studies have performed: Other studies utilizing mobile health interventions for cardiovascular disease management have shown promising results, indicating potential for success in this approach.

Eligibility criteria

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.

Where this trial is running

Buenos Aires

• Iecs Instituto de Efectividad Clinica Y Sanitaria — Buenos Aires, Argentina (Recruiting)

Study contacts

• Principal investigator: Thomas A Gaziano, MD, MSc — Harvard School of Public Health (HSPH)
• Study coordinator: Shafika Abrahams-Gessel, AB, MS, DRPH

Conditions Cardiovascular Diseases