Hypertension, Stroke
Conditions
Keywords
hypertension treatment, stroke prevention
Brief summary
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.
Detailed description
This is a randomized controlled trial of text messaging and blood pressure self-monitoring to reduce blood pressure.
Interventions
BEHAVIORALText Messaging
hypertensive participants will be randomized to receive tailored, motivational text messages
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
Inclusion criteria
* Adult (\>18 y/o) participants with BP ≥140/90 who have mobile phones with text-messaging capability.
Exclusion criteria
* Adult who is illiterate, non-English speaking, pregnant, incarcerated/ institutionalized resident, or has a pre-existing condition that makes follow-up for 6 months unlikely.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Systolic Blood Pressure | Baseline to 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in Diastolic Blood Pressure | Baseline to 6 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| No Text Messages, Hypertensive Participants who have high blood pressure, who are randomized to health information (do not receive text messages). | 46 |
| 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 | 48 |
| Total | 94 |
Baseline characteristics
| Characteristic | Text Messages, Hypertensive | Total | No Text Messages, Hypertensive |
|---|---|---|---|
| Age, Continuous | 58 years STANDARD_DEVIATION 8.5 | 58 years STANDARD_DEVIATION 9.8 | 59 years STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 47 Participants | 92 Participants | 45 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United States | 48 Participants | 94 Participants | 46 Participants |
| Sex: Female, Male Female | 38 Participants | 74 Participants | 36 Participants |
| Sex: Female, Male Male | 10 Participants | 20 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 46 | 0 / 48 |
| serious Total, serious adverse events | 0 / 46 | 0 / 48 |
Outcome results
Primary
Mean Change in Systolic Blood Pressure
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | Change from baseline | -14.4 mmHg | Standard Deviation 26.4 |
| No Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | Baseline | 162.2 mmHg | Standard Deviation 20.5 |
| No Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | 6 months | 146.7 mmHg | Standard Deviation 20.5 |
| Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | Change from baseline | -11.3 mmHg | Standard Deviation 22.9 |
| Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | Baseline | 160.7 mmHg | Standard Deviation 23.6 |
| Text Messages, Hypertensive | Mean Change in Systolic Blood Pressure | 6 months | 147.2 mmHg | Standard Deviation 21.8 |
p-value: 0.6t-test, 2 sided
Secondary
Mean Change in Diastolic Blood Pressure
Time frame: Baseline to 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| No Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | Change from baseline | -9.5 mmHg | Standard Deviation 12.9 |
| No Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | Baseline | 99.2 mmHg | Standard Deviation 17.8 |
| No Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | 6 months | 88.5 mmHg | Standard Deviation 11.5 |
| Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | Change from baseline | -8.6 mmHg | Standard Deviation 15.9 |
| Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | Baseline | 99.0 mmHg | Standard Deviation 11.8 |
| Text Messages, Hypertensive | Mean Change in Diastolic Blood Pressure | 6 months | 89.4 mmHg | Standard Deviation 13.9 |
p-value: 0.79t-test, 2 sided