Cardiovascular Precision Medicine & Remote Intervention

NCT ID: NCT05814562

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2024-10-25

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

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Remote Intervention

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.

Group Type: EXPERIMENTAL

Remote Intervention

Intervention Type: BEHAVIORAL

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.

Interventions

Remote Intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Edward-Elmhurst Health System

OTHER

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Eyal Shemesh

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eyal Shemesh, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Deborah Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

Edward-Elmhurst Health System

Locations

Elmhurst Hospital Center

New York, New York, United States

Countries

United States

References

Shemesh E, Reynolds D, Sidhu J, Duncan-Park S, Tejiram RA, Davison BA, Takagi K, Edwards C, Rubinstein D, Annunziato RA, Cotter G. Reducing blood pressure variability-results from a single-arm proof of concept prospective trial. Sci Rep. 2025 Aug 12;15(1):29449. doi: 10.1038/s41598-025-14968-z.

Reference Type: DERIVED

PMID: 40790229 (View on PubMed)

Reynolds D, Annunziato RA, Sidhu J, Cotter G, Davison BA, Takagi K, Duncan-Park S, Rubinstein D, Shemesh E. Cardiovascular Precision Medicine and Remote Intervention Trial Rationale and Design. J Clin Med. 2024 Oct 21;13(20):6274. doi: 10.3390/jcm13206274.

Reference Type: DERIVED

PMID: 39458224 (View on PubMed)

Other Identifiers

STUDY-22-00680

Identifier Type: -

Identifier Source: org_study_id