Clinical trial NCT05511701: Preventing Ischemic Heart Disease With mHealth (Mobile Health), Electronic Decision Support and Community Health Workers
Official title: Preventing Ischemic Heart Disease With mHealth, Electronic Decision Support, and Community Health Workers (PRIMECare Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases (CVD)
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 954
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Difference in mean change in absolute CVD risk, calculated using the Framingham cardiovascular disease lab-based risk equation, between study arms at 12 months
timeFrame: At enrollment (baseline) and 12 months after enrollment
Secondary outcomes:
measure: Difference in mean change in LDL-C between study arms at 12 months
timeFrame: At enrollment (baseline) and 12 months after enrollment
measure: Difference in mean change in systolic blood pressure between study arms at 12 months
timeFrame: At enrollment (baseline) and 12 months after enrollment
measure: Changes in smoking rates over 12-month study period
timeFrame: At enrollment (baseline) and 12 months after enrollment
measure: Medical costs incurred over 12-month study period
timeFrame: From enrollment to end of the study period at 12 months
measure: Medication possession ratios at 12 months between study arms
timeFrame: At 12 months after enrollment
measure: Medication intensity changes
timeFrame: From enrollment to end of the study period at 12 months
measure: Major adverse reactions for statins and anti-hypertension medications
timeFrame: From enrollment to end of the study period at 12 months
measure: Quality adjusted life years (QALYs)
timeFrame: From enrollment to end of the study period at 12 months
measure: 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.
timeFrame: 6 weeks from enrollment.
measure: 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.
timeFrame: 4 months from enrollment
measure: Number of clinical visits between study arms at 12 months
timeFrame: From enrollment to end of the study period at 12 months
measure: Health utilization outcomes
timeFrame: From enrollment to end of the study period at 12 months
measure: Mortality
timeFrame: From the start of enrollment to 12, then 60 months after enrollment
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Iecs Instituto de Efectividad Clinica Y Sanitaria
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Thomas A Gaziano, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: