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| ID | Type | Description | Link |
|---|---|---|---|
| P50MD017338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The overall goal of this project is to determine if measuring blood pressure at home and staying in contact with a team of pharmacists and physicians to manage your blood pressure is feasible. The study will enroll 24 participants at UAB who are seen at the Emergency Department Post-Discharge Clinic. Half of the participants (12 patients) will be asked to measure their blood pressure at home, and half of the participants (12 patients) will continue to receive usual care. Participants who measure their blood pressure at home will also meet with a pharmacist weekly over the phone to discuss blood pressure readings and have blood pressure medications prescribed if needed. This program will last 3 months.
For all participants:
For participants asked to measure blood pressure at home:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Placebo Comparator | Participants receive usual care from providers to manage their blood pressure |
|
| Remote Blood Pressure Monitoring + Telehealth | Active Comparator | Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Blood Pressure Monitoring + Telehealth | Other | Remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Recruited Participants | Number of participants enrolled into the study after screening and eligibility confirmation. | 2 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Attended Last Study Visit | Number of participants who completed the final study visit conducted approximately three months after randomization. | 3 months from randomization |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lama Ghazi, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States |
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24 participants who were eligible were enrolled.
27 participants were screened and 24 were eligible and were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 12 participants were randomized to usual care arm. |
| FG001 | Intervention | 12 participants were randomized to remote blood pressure monitoring |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Characteristics of 24 patients enrolled and randomized in the pilot study
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | 12 participants were randomized to usual care arm. |
| BG001 | Intervention | 12 participants were randomized to remote blood pressure monitoring and pharamcist led Telehealth monitoring |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of participants at enrollment |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Recruited Participants | Number of participants enrolled into the study after screening and eligibility confirmation. | Overall Number of Participants Analyzed represents the number of participants screened for study interest prior to enrollment. Of 27 screened, 24 were eligible and successfully enrolled. | Posted | Count of Participants | Participants | 2 years |
|
|
3 months
0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Participants receive usual care from providers to manage their blood pressure |
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This study was a small single-center pilot randomized study designed to evaluate feasibility of recruitment and retention for a remote blood pressure monitoring and pharmacist-led telehealth program. The study was not powered to evaluate clinical effectiveness of the intervention. In addition, follow-up was limited to three months and not all participants completed the final study visit.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lama Ghazi, MD PhD | University of Alabama at Birmingham | 205-975-5792 | lghazi@uab.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2024 | Apr 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Usual care | Other | Participants receive usual care, no intervention. |
|
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Female, sex of participants | Sex of participants | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race of participants | Count of Participants | Participants |
|
|
|
| Other Pre-specified | Number of Participants Who Attended Last Study Visit | Number of participants who completed the final study visit conducted approximately three months after randomization. | Posted | Number | number of participants | 3 months from randomization |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Remote Blood Pressure Monitoring + Telehealth | Participants will undergo remote blood pressure monitoring and pharmacist led telehealth intervention for blood pressure management | 0 | 12 | 0 | 12 | 0 | 12 |
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