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Cardiovascular Precision Medicine & Remote Intervention (CP&R)

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote Intervention
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 detrermines 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.

Sites / Locations

  • Elmhurst Hospital CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remote Intervention

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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 8 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.
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 12 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.
Proportion of clinic patients "at risk"
The proportion of patients who display an "at risk" pattern will be computed as the number of patients with a CoV of at least three systolic blood pressure measurements present in the EHR over the 6 months prior to screening > 10% out of the number of patients meeting all eligibility criteria identifiable during screening of the EHR. The proportion and its associated 90% CI will be presented.
Proportion of high risk who agree to participate
The proportion of "high risk" patients who agree to participate will be computed as the number of patients who sign the informed consent form out of the number of patients identified as meeting all study eligibility criteria and approached for informed consent. The proportion and its associated 90% CI will be presented.
Proportion of high risk patients successfully engaged
The proportion of "high risk" patients successfully engaged will be computed as the number of patients who participate in 3 more more remote intervention sessions out of the number of patients who agree to participate in the study. The proportion and its associated 90% CI will be presented.
Change in cholesterol level
The changes from in total, LDL, HDL cholesterol levels; and in triglyceride levels from Visit 1 (enrollment; defined as the last measure taken for clinical reasons prior to consent or during the visit in which consent was obtained) to Visit 9 (week 12) will be tested using paired t-tests.
Change in blood pressure
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.

Full Information

First Posted
April 3, 2023
Last Updated
April 17, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Edward-Elmhurst Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05814562
Brief Title
Cardiovascular Precision Medicine & Remote Intervention
Acronym
CP&R
Official Title
Cardiovascular Precision Medicine & Remote Intervention - Pilot Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai
Collaborators
Edward-Elmhurst Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-intervention versus post intervention evaluations
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remote Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Remote Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Blood pressure readings
Description
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 Outcome Measure Information:
Title
Change in Blood Pressure Variability Index
Description
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
Title
Change in Blood Pressure Variability Index
Description
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.
Time Frame
6 months prior to screening and Week 4
Title
Change in Blood Pressure Variability Index
Description
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 8 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 8
Title
Change in Blood Pressure Variability Index
Description
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 12 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 12
Title
Proportion of clinic patients "at risk"
Description
The proportion of patients who display an "at risk" pattern will be computed as the number of patients with a CoV of at least three systolic blood pressure measurements present in the EHR over the 6 months prior to screening > 10% out of the number of patients meeting all eligibility criteria identifiable during screening of the EHR. The proportion and its associated 90% CI will be presented.
Time Frame
Baseline
Title
Proportion of high risk who agree to participate
Description
The proportion of "high risk" patients who agree to participate will be computed as the number of patients who sign the informed consent form out of the number of patients identified as meeting all study eligibility criteria and approached for informed consent. The proportion and its associated 90% CI will be presented.
Time Frame
Baseline
Title
Proportion of high risk patients successfully engaged
Description
The proportion of "high risk" patients successfully engaged will be computed as the number of patients who participate in 3 more more remote intervention sessions out of the number of patients who agree to participate in the study. The proportion and its associated 90% CI will be presented.
Time Frame
12 weeks
Title
Change in cholesterol level
Description
The changes from in total, LDL, HDL cholesterol levels; and in triglyceride levels from Visit 1 (enrollment; defined as the last measure taken for clinical reasons prior to consent or during the visit in which consent was obtained) to Visit 9 (week 12) will be tested using paired t-tests.
Time Frame
Visit 1 (Week 0) and Visit 9 (Week 12)
Title
Change in blood pressure
Description
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.
Time Frame
Visit 1 (Week 0) and Visit 9 (Week 12)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 detrermines 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eyal Shemesh, MD
Phone
2122412842
Email
eyal.shemesh@mssm.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Deborah Reynolds, MD
Phone
2122412842
Email
reynoldd@nychhc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eyal Shemesh, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Deborah Reynolds, MD
Organizational Affiliation
Edward-Elmhurst Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elmhurst Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
11373
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deborah Reynolds, MD
Phone
212-241-2842
Email
reynoldd@nychhc.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Pilot study

Learn more about this trial

Cardiovascular Precision Medicine & Remote Intervention

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