Cardiovascular Diseases (CVD)PRIMECareNCT05511701
Preventing Ischemic Heart Disease With mHealth (Mobile Health), Electronic Decision Support and Community Health Workers
A study testing CHW Care Model in people with Cardiovascular Diseases (CVD), run by Harvard School of Public Health (HSPH) at 1 site in Argentina.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Cardiovascular Diseases (CVD)
- What is being tested?
- CHW Care Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 968 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Oct 2022to 21 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Iecs Instituto de Efectividad Clinica Y Sanitaria
Buenos Aires
About this study
Official title: 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.
Read the 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)
- Being tested
- CHW Care Model, Usual Care Model
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHW Care ModelBehavioural
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
Usual Care ModelBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | with paper-based guidelines used by community health workers (CHW) and providers Receives: 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 Receives: Behavioral: CHW Care Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At enrollment (baseline) and 12 months after enrollment
Secondary outcomes (13)
Difference in mean change in LDL-C between study arms at 12 months
The difference in mean change in LDL-C between study arms.
Measured: 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.
Measured: 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
Measured: At enrollment (baseline) and 12 months after enrollment
Medical costs incurred over 12-month study period
The difference in medical costs between study arms
Measured: 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
Measured: At 12 months after enrollment
Medication intensity changes
Number of treatment intensity changes for statins and anti-hypertension medications in the intervention arm
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 4 months from enrollment
Number of clinical visits between study arms at 12 months
Number of clinical visits by participants to primary care clinics
Measured: 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
Measured: From enrollment to end of the study period at 12 months
Mortality
Number of deaths from all causes
Measured: From the start of enrollment to 12, then 60 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start14 Oct 2022
- Primary completion21 Sep 2026
- Study completion21 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Diseases (CVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 968 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Gaziano, Harvard School of Public Health (HSPH)
- Investigators
- Thomas A Gaziano, MD, MSc, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511701
- Sponsor's protocol ID
- IRB20-1166
- Acronym
- PRIMECare
- Status last verified
- Oct 2026
- First submitted
- 5 Aug 2022
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Ischemic Heart Disease With mHealth, Electronic Decision Support, and Community Health Workers (PRIMECare Trial)
- ClinicalTrials.gov ID
- NCT05511701
- Acronym / sponsor ID
- PRIMECare / IRB20-1166
- Conditions
- Cardiovascular Diseases (CVD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 968 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 21 Sep 2026 (actual)
- Study completion
- 21 Sep 2026 (actual)
- First posted
- 23 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual Care Modelwith paper-based guidelines used by community health workers (CHW) and providers |
| Intervention | Experimental | Behavioral: CHW Care Modelwith 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 |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHW Care ModelThe 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 | Behavioural | Intervention |
| Usual Care ModelAll 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. | Behavioural | Usual Care |
Primary outcome
Difference in mean change in absolute CVD risk, calculated using the Framingham cardiovascular disease lab-based risk equation, between study arms at 12 months
Time frame: At enrollment (baseline) and 12 months after enrollment
The difference in mean change in 10-year CVD risk between study arms
13 secondary outcomes
Difference in mean change in LDL-C between study arms at 12 months
Time frame: At enrollment (baseline) and 12 months after enrollment
Difference in mean change in systolic blood pressure between study arms at 12 months
Time frame: At enrollment (baseline) and 12 months after enrollment
Changes in smoking rates over 12-month study period
Time frame: At enrollment (baseline) and 12 months after enrollment
Medical costs incurred over 12-month study period
Time frame: From enrollment to end of the study period at 12 months
Medication possession ratios at 12 months between study arms
Time frame: At 12 months after enrollment
Medication intensity changes
Time frame: From enrollment to end of the study period at 12 months
Major adverse reactions for statins and anti-hypertension medications
Time frame: From enrollment to end of the study period at 12 months
Quality adjusted life years (QALYs)
Time frame: 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.
Time frame: 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.
Time frame: 4 months from enrollment
Number of clinical visits between study arms at 12 months
Time frame: From enrollment to end of the study period at 12 months
Health utilization outcomes
Time frame: From enrollment to end of the study period at 12 months
Mortality
Time frame: From the start of enrollment to 12, then 60 months after enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas A Gaziano, MD, MSc principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHW Care Model in people with Cardiovascular Diseases (CVD), run by Harvard School of Public Health (HSPH) at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: At enrollment (baseline) and 12 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.