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

President and Fellows of Harvard College

Status: Enrolling

Conditions: Cardiovascular Diseases (CVD)

Treatments: Behavioral: CHW Care Model; Behavioral: Usual Care Model

Study type: Interventional

Funder types: Other

Identifiers

NCT05511701

IRB20-1166

Details and patient eligibility

About

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.

Full description

954 eligible women and men aged 40-74 with high CVD risk living in the catchment area of 18 primary care clinics (PCCs) in 3 different provinces (Quilmes, La Rioja, and San Juan) in Argentina will be recruited for the study. Eighteen PCCs will be randomized to either the usual care (control) arm or the intervention arm (3 usual care and 3 intervention PCCs in each province). Participants who reside in the catchment area of intervention PCCs will receive the multicomponent intervention with central data management system linking digital mHealth (mobile health) screening tool for CHWs, electronic appointment scheduling which is integrated with the clinic electronic appointment system, point of care testing (POCT) for lipids, clinical decision support for medication initiation, and a SMS reminder system for adherence to medications and life-style changes, while participants who reside in the catchment area of usual care PCCs will receive usual care with paper-based guidelines used by community health workers and providers. The recruitment goals are 477 persons in the intervention arm and 477 in the usual care arm. Participants will be enrolled for a 12 month study period from baseline visit, and the primary outcome is mean difference in absolute 10-year CVD risk.

Enrollment: 954 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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954 participants in 2 patient groups

Usual Care

Active Comparator group

Description:

with paper-based guidelines used by community health workers (CHW) and providers

Treatment:

Behavioral: Usual Care Model

Intervention

Experimental group

Description:

with central data management system linking digital mHealth screening tool for CHWs, electronic appointment scheduling, point of care testing (POCT) for lipids, clinical decision support for medication initiation, and a SMS reminder system for adherence to medications and life-style changes

Treatment:

Behavioral: CHW Care Model