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

NCT05511701 | Active Not Recruiting

• 1 other identifier: IRB20-1166
• Study Type: interventional
• Target: 968
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases (CVD)

Outcome Measures

Primary Outcomes (1)

• Difference in mean change in absolute CVD risk, calculated using the Framingham cardiovascular disease lab-based risk equation, between study arms at 12 months

  The difference in mean change in 10-year CVD risk between study arms

  At enrollment (baseline) and 12 months after enrollment

Secondary Outcomes (13)

• Difference in mean change in LDL-C between study arms at 12 months

  At enrollment (baseline) and 12 months after enrollment

• Difference in mean change in systolic blood pressure between study arms at 12 months

  At enrollment (baseline) and 12 months after enrollment

• Changes in smoking rates over 12-month study period

  At enrollment (baseline) and 12 months after enrollment

• Medical costs incurred over 12-month study period

  From enrollment to end of the study period at 12 months

• Medication possession ratios at 12 months between study arms

  At 12 months after enrollment

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

Behavioral: Usual Care Model

Intervention

EXPERIMENTAL

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

Behavioral: CHW Care Model

Interventions

CHW Care Model 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

Intervention

Usual Care Model 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.

Usual Care

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard School of Public Health (HSPH): lead

Study Sites (1)

Iecs Instituto de Efectividad Clinica Y Sanitaria

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Thomas A Gaziano, MD, MSc

  Harvard School of Public Health (HSPH)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2022
• First Posted: August 23, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: After the date of study closure up to 5 years.
• Access Criteria: Investigators who wish to use the data will be required to send a detailed proposal, including an analytic plan, to the primary investigator for review.

Locations

AR (1)