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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases (CVD)
• Intervention / Treatment: Behavioral: Usual Care Model; Behavioral: CHW Care Model

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.

• Study Type: Interventional
• Enrollment (Estimated): 954
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shafika Abrahams-Gessel, AB, MS< DRPH; Phone Number: 6174324385; Email: sabraham@hsph.harvard.edu

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Recruiting
    • Iecs Instituto de Efectividad Clinica Y Sanitaria
    • Contact: Andrea Beratarrechea; Email: aberatarrechea@iecs.org.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care; with paper-based guidelines used by community health workers (CHW) and providers	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.
Experimental: 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in mean change in LDL-C between study arms at 12 months	The difference in mean change in LDL-C between study arms.	At enrollment (baseline) and 12 months after enrollment
Difference in mean change in systolic blood pressure between study arms at 12 months	The difference in mean change in systolic blood pressure between study arms.	At enrollment (baseline) and 12 months after enrollment
Changes in smoking rates over 12-month study period	The difference in mean smoking rates between study arms	At enrollment (baseline) and 12 months after enrollment
Medical costs incurred over 12-month study period	The difference in medical costs between study arms	From enrollment to end of the study period at 12 months
Medication possession ratios at 12 months between study arms	Ratio of prescribed statins and anti-hypertension medications in participants' possession	At 12 months after enrollment
Medication intensity changes	Number of treatment intensity changes for statins and anti-hypertension medications in the intervention arm	From enrollment to end of the study period at 12 months
Major adverse reactions for statins and anti-hypertension medications	Number of reported adverse reactions for statins and anti-hypertension medications in intervention arm	From enrollment to end of the study period at 12 months
Quality adjusted life years (QALYs)	Summary of the impact the intervention on CVD risk	From enrollment to end of the study period at 12 months
Proportion of patients with a 10-year CVD risk ≥ 10% that complete a first visit at the local clinic within 6 weeks after enrollment in the study.	Proportion of patients with a 10-year CVD risk ≥ 10% that complete a visit at the local clinic within 6 weeks after enrollment in the study.	6 weeks from enrollment.
Proportion of patients with a 10-year CVD risk ≥ 10% that complete a first visit at the local clinic within 4 months after enrollment in the study.	Proportion of patients with a 10-year CVD risk ≥ 10% that complete a first visit at the local clinic within 4 months after enrollment in the study.	4 months from enrollment
Number of clinical visits between study arms at 12 months	Number of clinical visits by participants to primary care clinics	From enrollment to end of the study period at 12 months
Health utilization outcomes	Number of hospitalizations, emergency room visits, outpatient visits and procedures, and primary care clinic visits	From enrollment to end of the study period at 12 months
Mortality	Number of deaths from all causes	From the start of enrollment to 12, then 60 months after enrollment

Collaborators and Investigators

• Sponsor: Harvard School of Public Health (HSPH)
• Investigators: Principal Investigator: Thomas A Gaziano, MD, MSc, Harvard School of Public Health (HSPH)

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases
• Other Study ID Numbers: IRB20-1166

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Because of the sensitive nature of the data collected for this study, requests to access the data set from qualified researchers trained in human subject confidentiality protocols may be sent to the primary investigator.
• IPD Sharing Time Frame: After the date of study closure up to 5 years.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No