Cardiovascular Precision Medicine & Remote Intervention

Icahn School of Medicine at Mount Sinai25 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertension

Interventions

Remote InterventionBEHAVIORAL

The study utilizes a tailored telemetric intervention to improve adherence to medications. The telemetric intervention (administered via telephone, or interactive internet chat applications such as Zoom ©, FaceTime ® or Skype ®) will enable experienced therapists to address nonadherence from a remote location, using a structured, tailored approach that accommodates specific patient needs.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Elmhurst Hospital Center

New York, New York, United States

Outcomes

Primary Outcomes

Change in Blood pressure readings

The change in systolic blood pressure from Visit 1 (enrollment) to Visit 9 (week 12) will be tested using a paired t-test. Changes will be based on measures taken with the same monitor (clinic or home) at both time points if possible; if changes with both clinic and home monitors are available, then measures using the clinic monitor will be used. Blood pressure readings (min max mean and fluctuation) before the intervention commences and during and after it, in an intent-to treat paradigm.

Time frame: Baseline and Week 12

Secondary Outcomes

Change in Blood Pressure Variability Index

A blood pressure variability index (BPVI) will be defined as the standard deviation (SD) of selected blood pressure measurements. A BPCoV will also be defined as the coefficient of variation of selected systolic blood pressure measurements. The BPVI over the 6 months prior to EHR screening (at least 3 measurements per eligibility criteria); and of measures at study visit at week 2 will be computed. BPCoV measures will be computed analogously. If no measure is available at a particular week, the closest measure in time will be used. Only patients with at least 3 post-enrollment BP measurements will be included in the analyses. Measures before and after enrollment will be compared with a paired t-test. BPVI will be considered the primary analysis, with analysis of BPCoV supportive.

Time frame: 6 months prior to screening and Week 2

Change in Blood Pressure Variability Index

A blood pressure variability index (BPVI) will be defined as the standard deviation (SD) of selected blood pressure measurements. A BPCoV will also be defined as the coefficient of variation of selected systolic blood pressure measurements. The BPVI over the 6 months prior to EHR screening (at least 3 measurements per eligibility criteria); and of measures at study visit at week 4 will be computed. BPCoV measures will be computed analogously. If no measure is available at a particular week, the closest measure in time will be used. Only patients with at least 3 post-enrollment BP measurements will be included in the analyses. Measures before and after enrollment will be compared with a paired t-test. BPVI will be considered the primary analysis, with analysis of BPCoV supportive.

Data from ClinicalTrials.gov

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