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| Name | Class |
|---|---|
| Edward-Elmhurst Health System | OTHER |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
Exclusion Criteria:
None of the following may be present if the patient is to be eligible for enrollment in the study:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Shemesh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Deborah Reynolds, MD | Edward-Elmhurst Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elmhurst Hospital Center | New York | New York | 11373 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40790229 | Derived | 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. | |
| 39458224 | Derived |
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Pilot study
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Pre-intervention versus post intervention evaluations
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| 6 months prior to screening and Week 2 |
| 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. | 6 months prior to screening and Week 4 |
| 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. | 6 months prior to screening and Week 8 |
| 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. | 6 months prior to screening and Week 12 |
| 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. | Baseline |
| 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. | Baseline |
| 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. | 12 weeks |
| 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. | Visit 1 (Week 0) and Visit 9 (Week 12) |
| 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. | Visit 1 (Week 0) and Visit 9 (Week 12) |
| 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. |