MedTrace Logo

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

NCT05511701 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 968

Last updated 2026-02-23

No results posted yet for this study

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.

Conditions

  • Cardiovascular Diseases (CVD)

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • Harvard School of Public Health (HSPH)

    lead OTHER

Principal Investigators

  • Thomas A Gaziano, MD, MSc · Harvard School of Public Health (HSPH)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-14
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • Argentina

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05511701 on ClinicalTrials.gov