Cardiovascular Precision Medicine & Remote Intervention

NCT05814562 | Completed

• 1 other identifier: STUDY-22-00680
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Week 12

Secondary Outcomes (9)

• Change in Blood Pressure Variability Index

  6 months prior to screening and Week 2

• Change in Blood Pressure Variability Index

  6 months prior to screening and Week 4

• Change in Blood Pressure Variability Index

  6 months prior to screening and Week 8

• Change in Blood Pressure Variability Index

  6 months prior to screening and Week 12

• Proportion of clinic patients "at risk"

  Baseline

Study Arms (1)

Remote Intervention

EXPERIMENTAL

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.

Behavioral: Remote Intervention

Interventions

Remote Intervention 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.

Remote Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Edward-Elmhurst Health System: collaborator

Study Sites (1)

Elmhurst Hospital Center

New York, New York, 11373, United States

Location

Related Publications (2)

• 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.

  PMID: 40790229 DERIVED

• 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.

  PMID: 39458224 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eyal Shemesh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Deborah Reynolds, MD

  Edward-Elmhurst Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Pre-intervention versus post intervention evaluations

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: April 10, 2023
• Primary Completion: October 25, 2024
• Study Completion: October 25, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)