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One of the most powerful predictors of stroke is hypertension, with estimates of approximately 33% of adults in the United States experiencing this condition. Hypertension is significantly more prevalent in African Americans compared to European Americans. Importantly, hypertension is a modifiable stroke risk factor.
This proposal will use a community-based participatory research approach to perform a randomized trial of a mobile phone text-messaging intervention to reduce high blood pressure in an urban African American community in Flint, Michigan.
This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No text messages, hypertensive | No Intervention | Participants who have high blood pressure, who are randomized to health information (do not receive text messages). | |
| Text messages, hypertensive | Experimental | Participants who have high blood pressure, who are randomized to receive text messages. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Text Messaging | Behavioral | hypertensive participants will be randomized to receive tailored, motivational text messages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Systolic Blood Pressure | Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Diastolic Blood Pressure | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lesli Skolarus | University of Michigan | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Text Messages, Hypertensive | Participants who have high blood pressure, who are randomized to health information (do not receive text messages). |
| FG001 | Text Messages, Hypertensive | Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Text Messages, Hypertensive | Participants who have high blood pressure, who are randomized to health information (do not receive text messages). |
| BG001 | Text Messages, Hypertensive |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Mean Change in Systolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline to 6 months |
|
6 months
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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 | No Text Messages, Hypertensive | Participants who have high blood pressure, who are randomized to health information (do not receive text messages). |
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high lost to follow up rate. Unknown why participants did not complete the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lesli Skolarus | University of Michigan | 734-936-9075 | lerusche@umich.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
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Participants who have high blood pressure, who are randomized to receive text messages.
Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
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| Secondary | Mean Change in Diastolic Blood Pressure | Posted | Mean | Standard Deviation | mmHg | Baseline to 6 months |
|
|
|
|
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Text Messages, Hypertensive | Participants who have high blood pressure, who are randomized to receive text messages. Text Messaging: hypertensive participants will be randomized to receive tailored, motivational text messages | 0 | 48 | 0 | 48 |
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| 6 months |
|