Clinical trial NCT05814562: Cardiovascular Precision Medicine & Remote Intervention
Official title: Cardiovascular Precision Medicine & Remote Intervention - Pilot Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Edward-Elmhurst Health System
First posted: 2023-04-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pre-intervention versus post intervention evaluations
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility 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.

Primary outcomes:
measure: Change in Blood pressure readings
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Blood Pressure Variability Index
timeFrame: 6 months prior to screening and Week 2
measure: Change in Blood Pressure Variability Index
timeFrame: 6 months prior to screening and Week 4
measure: Change in Blood Pressure Variability Index
timeFrame: 6 months prior to screening and Week 8
measure: Change in Blood Pressure Variability Index
timeFrame: 6 months prior to screening and Week 12
measure: Proportion of clinic patients "at risk"
timeFrame: Baseline
measure: Proportion of high risk who agree to participate
timeFrame: Baseline
measure: Proportion of high risk patients successfully engaged
timeFrame: 12 weeks
measure: Change in cholesterol level
timeFrame: Visit 1 (Week 0) and Visit 9 (Week 12)
measure: Change in blood pressure
timeFrame: Visit 1 (Week 0) and Visit 9 (Week 12)
Other outcomes:
Locations:
city: New York
country: United States
facility: Elmhurst Hospital Center
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Eyal Shemesh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Edward-Elmhurst Health System
name: Deborah Reynolds, MD
role: PRINCIPAL_INVESTIGATOR
References: