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| Name | Class |
|---|---|
| University of Missouri-Columbia | OTHER |
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The purpose of this study is to evaluate changes in patient knowledge of blood pressure management and perceptions of making lifestyle changes to manage their blood pressure after implementation of an evidence-based one-page teaching protocol with supplemental handouts and optional use of suggested apps and web sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BP Education | Other | All participants enrolled receive blood pressure education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood pressure education | Behavioral | One page teaching protocol performed by pharmacy students; phone follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Pre & Post Survey & Knowledge Test | change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BP Education Helpfulness | All participants enrolled receive blood pressure education; measured patient's perceived helpfulness of educational one-page handout in a post-survey | 8 weeks |
| BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walgreens Store #6587 | Albuquerque | New Mexico | 87112 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | BP Education | All participants enrolled receive blood pressure education. Blood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 10, 2020 |
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change in participant's confidence in managing disease state as measured by pre & post survey |
| 8 weeks |
| COMPLETED |
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| NOT COMPLETED |
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A total of 5 participants received the information, participated in follow-up phone calls, and returned all of their information in the provided SASE to the clinic.
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| ID | Title | Description |
|---|---|---|
| BG000 | BP Education | All participants enrolled receive blood pressure education. Blood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Pre & Post Survey & Knowledge Test | change in participant's knowledge of blood pressure management as measured by a pre- and post-test of 10 multiple-choice questions | Posted | Mean | Full Range | percentage of questions answered correct | 8 weeks |
|
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| |||||||||||||||||||||||||||||||||
| Secondary | BP Education Helpfulness | All participants enrolled receive blood pressure education; measured patient's perceived helpfulness of educational one-page handout in a post-survey | Posted | Count of Participants | Participants | 8 weeks |
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| Secondary | BP Education - Change in Confidence in Managing Disease State (Pre & Post Survey) | change in participant's confidence in managing disease state as measured by pre & post survey | Posted | Count of Participants | Participants | 8 weeks |
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After enrollment, packet was mailed to participant and future phone call time frames set up to be able to call the participants back for an initial call to ensure packet received within one week of enrollment; with follow-up at 4 weeks after enrollment, 8 weeks after enrollment, and then a final phone call to ensure information would be mailed back at up to 4 weeks after the final phone call.
As the intervention was a survey and phone call, no serious adverse events were expected and none were reported by participants within one week; 4 weeks, or 8 weeks,or when contacted to ensure information would be mailed back at up to 4 weeks after the final phone call (within a maximum of 12 weeks of enrollment).
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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 | BP Education | All participants enrolled receive blood pressure education. Blood pressure education: One page teaching protocol performed by pharmacy students; phone follow-up | 0 | 5 | 0 | 5 | 0 | 5 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Herman | University of New Mexico College of Pharmacy | 505-272-7630 | asible@salud.unm.edu |
| Jul 6, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2020 | Mar 12, 2021 | ICF_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Title | Denominators | Categories |
|---|
| Helpful - Yes |
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| Helpful - NO |
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| Title | Denominators | Categories |
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| Pre-Survey |
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| Post-Survey |
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