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Completed

NCT Number: NCT05814562

Cardiovascular Precision Medicine & Remote Intervention

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elmhurst Hospital Center

New York, 11373, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Change in Blood pressure readings

    Time frame: Baseline and Week 12

    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 outcomes

  1. Change in Blood Pressure Variability Index

    Time frame: 6 months prior to screening and Week 2

    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.

  2. Change in Blood Pressure Variability Index

    Time frame: 6 months prior to screening and Week 4

    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.

  3. Change in Blood Pressure Variability Index

    Time frame: 6 months prior to screening and Week 8

    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.

  4. Change in Blood Pressure Variability Index

    Time frame: 6 months prior to screening and Week 12

    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.

  5. Proportion of clinic patients "at risk"

    Time frame: Baseline

    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.

  6. Proportion of high risk who agree to participate

    Time frame: Baseline

    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.

  7. Proportion of high risk patients successfully engaged

    Time frame: 12 weeks

    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.

  8. Change in cholesterol level

    Time frame: Visit 1 (Week 0) and Visit 9 (Week 12)

    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.

  9. Change in blood pressure

    Time frame: Visit 1 (Week 0) and Visit 9 (Week 12)

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Edward-Elmhurst Health System

Registry information

Official study title

Cardiovascular Precision Medicine & Remote Intervention - Pilot Protocol

Acronym: CP&R

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 18, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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