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

NCT ID: NCT05511701

Last Updated: 2025-09-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 954 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-14
• Study Completion Date: 2026-07-31

Brief 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.

Detailed 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.

Conditions

Cardiovascular Diseases (CVD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Usual Care Model

Intervention Type: BEHAVIORAL

All study participants will be visited in their home by a CHW and a nurse for eligibility assessment, screening, and enrollment. The CHW will then measure the participant's blood pressure and the readings along with other demographic variables already collected, to calculate the participant's absolute CVD risk score. In the usual care arm the CHW will use the WHO paper-based non-lab CVD risk calculator and, if the participant's risk is \> 10%, they are asked to sign the informed consent and s/he will have their cholesterol tested by nurses using POCT during a home enrollment visit. The CHW will further verbally encourage her/him to schedule an appointment with a primary care physician at the PCC for evaluation. This is the usual care practice.

Intervention

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

Group Type: EXPERIMENTAL

CHW Care Model

Intervention Type: BEHAVIORAL

The CHW will measure the participant's blood pressure (BP) and along with other demographic variables, calculate the participant's absolute CVD risk score, using the mHealth (mobile health) app. If the participant's risk is \> 10%, they are asked to sign the informed consent. The CHW will electronically schedule an appointment at the PCC. The participant will receive a SMS appointment confirmation. S/he will have their cholesterol tested by nurses using a home POCT. Nurses will repeat POCT lipids and BP measurements at all PCC visits and other clinical information will be entered into the electronic decision support tool that will generate a guideline based treatment recommendation for the physician. CHWs will make up to four home visits or telephone calls to intervention participants over the 12 month study period to check on medication adherence, as well as to determine if the patient is in possession of the medication

Interventions

CHW Care Model

The CHW will measure the participant's blood pressure (BP) and along with other demographic variables, calculate the participant's absolute CVD risk score, using the mHealth (mobile health) app. If the participant's risk is \> 10%, they are asked to sign the informed consent. The CHW will electronically schedule an appointment at the PCC. The participant will receive a SMS appointment confirmation. S/he will have their cholesterol tested by nurses using a home POCT. Nurses will repeat POCT lipids and BP measurements at all PCC visits and other clinical information will be entered into the electronic decision support tool that will generate a guideline based treatment recommendation for the physician. CHWs will make up to four home visits or telephone calls to intervention participants over the 12 month study period to check on medication adherence, as well as to determine if the patient is in possession of the medication

Intervention Type: BEHAVIORAL

Usual Care Model

All study participants will be visited in their home by a CHW and a nurse for eligibility assessment, screening, and enrollment. The CHW will then measure the participant's blood pressure and the readings along with other demographic variables already collected, to calculate the participant's absolute CVD risk score. In the usual care arm the CHW will use the WHO paper-based non-lab CVD risk calculator and, if the participant's risk is \> 10%, they are asked to sign the informed consent and s/he will have their cholesterol tested by nurses using POCT during a home enrollment visit. The CHW will further verbally encourage her/him to schedule an appointment with a primary care physician at the PCC for evaluation. This is the usual care practice.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Thomas Gaziano

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas A Gaziano, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Harvard School of Public Health (HSPH)

Locations

Iecs Instituto de Efectividad Clinica Y Sanitaria

Buenos Aires, , Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Shafika Abrahams-Gessel, AB, MS, DRPH

Role: CONTACT

sabraham@hsph.harvard.edu

6174324385

Facility Contacts

Pablo Gulayin

Role: primary

pgulayin@iecs.org.ar

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB20-1166

Identifier Type: -

Identifier Source: org_study_id