Cardiovascular Precision Medicine & Remote Intervention (CP&R)

Mount Sinai Health System

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Remote Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05814562

STUDY-22-00680

Details and patient eligibility

About

This exploratory / proof of concept study aims to evaluate whether it is possible to identify at-risk patients based on EHR review of blood pressure fluctuation over time and cholesterol levels, recruit those patients, and engage them in a remote intervention protocol.

Full description

Patients will be screened for participation based on EHR blood pressure measurements. Those who potential meet the prespecified criteria will be approached during a clinic visits about participation in the study. Patients who agree to participate and sign an informed consent will be given an automatic blood pressure monitor and their contact details will be obtained in order to enable administration of the intervention.

The intervention's theoretical underpinnings are principles previously identified as promising or helpful in health care management of at-risk patients. The principles are:

1. "Hovering", using a risk marker, to guide an intervention
2. Addressing posttraumatic avoidance as a way to improve adherence, using an imaginal exposure paradigm.
3. Using a remote interventionist via a telemetric interface that involves active, dynamic patient engagement rather than automated processes

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participants will be screened for eligibility using the eligibility criteria delineated below. Informed Consent will be obtained for eligible candidates.

Inclusion Criteria:

The patient must meet all of below criteria to be eligible for enrollment in the study:

• The patient is > 18 years of age at enrollment.
• The patient is followed at the cardiology clinic and was diagnosed with hypertension and hypercholesterolemia more than 12 months prior to EHR screening, and has been prescribed at least one antihypertensive medication and at least one lipid-lowering agent over the 6 months prior to EHR screening
• The patient can be reached either by phone or via an internet-enabled device.
• The patient speaks English or Spanish at a level that allows them to understand the study procedures and consent to the study.
• The coefficient of Variation (CoV) of at least three systolic blood pressure measurements present in the EHR over the 12 months prior to EHR screening is > 10%.

Exclusion Criteria:

None of the following may be present if the patient is to be eligible for enrollment in the study:

• The patient is suffering from a psychiatric or developmental disorder that prevents him or her from understanding the protocol or engaging in the intervention (e.g., autistic disorder, psychosis).
• The investigator determines that a remote intervention paradigm is not advisable because of specific patient or environmental characteristics (investigator discretion).
• The patient is suffering from a medical disorder that makes control of blood pressure especially challenging or unlikely (e.g., end stage renal disease, uncontrolled endocrine disorders)
• Unstable blood pressure or hyperlipidemia that may require change in therapy in the 3 months after enrolment
• Significant heart failure (NYHA > 2) or ejection fraction < 50%
• Recent thromboembolic events such as a myocardial infarction, stroke, acute coronary syndrome, transient ischemic attack in the 6 months prior to enrolment
• Any arrythmia requiring medical or device therapy within 6 months prior to enrolment.
• The patient is hospitalized or was hospitalized in the last 6 months prior to enrollment. Patients hospitalized after enrollment are not excluded.

PI decision to exclude (for example - PI determines that the patient may be harmed by the study for a reason that is not covered by the exclusion criteria)

Withdrawal Criteria

Participants will be withdrawn from the intervention if they wish to not be called anymore. If they agree to continue to have their data collected from the medical chart, they would not be withdrawn from the study. Patients will be withdrawn from the study (their pre-withdrawal data will be used for the primary intent-to-treat analysis unless prohibited) for the following reasons:

• The patient dies.
• The patient becomes psychotic as defined in DSM-V, or suffers from an event that makes him or her unable to participate in the intervention (e.g. loss of hearing, loss of cognitive ability).
• The patient's care is transferred to another center, and it is impossible to get the primary and secondary outcome data.
• Patient decision
• Investigator decision
• DSMC or IRB determination related to the occurrence of an adverse event, or for any other reason.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Remote Intervention

Experimental group

Description:

An automatic blood pressure monitor will be given to patients upon enrollment. During the three months after enrollment, patients will be administered remote intervention weekly during the first month, and biweekly during the second and third month. At the onset of those sessions the patients will be asked to measure their blood pressure and this will be recorded by the coordinator.

Treatment:

Behavioral: Remote Intervention