Hypertension
Conditions
Brief summary
The goal of this project is to develop and pilot test a research protocol to assess the influence of a health information behavior enhanced intervention on self-management, blood pressure control, and brain activity in African American women with hypertension. This work will identify characteristics of African American women that are associated with improved self-management and decreased blood pressure, and subsequent reduction of risk of heart disease and premature death. The results of this project will have direct impact in informing interventions to improve blood pressure control, by advancing our knowledge of brain activity associated with behavior change in African American women with hypertension in the metro-Detroit area, and ultimately everywhere.
Interventions
BEHAVIORALSharing Intervention
intervention includes both analytic and socioemotional components related to self-management of hypertension and is specifically targeted to African American women. Along with providing education on lifestyle changes to lower blood pressure, DASH diet, exercise, and medication adherence (analytic components), the intervention is designed to promote social activities around blood pressure self-management, in particular, sharing blood pressure management information with peers (socioemotional components).
Sponsors
University of Michigan
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria are (a) aged \>18, (b) clinically diagnosed with hypertension, and (c) right-handed (due to potential differences in brain morphology compared to left-handed individuals). \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain Activity | 6 months | fMRI protocol - Each participant was presented the same conditions, in the same order . A fixed sequence design was used because the primary goal was to compare patterns of brain activity between participants. Means are estimated averages of each participant's response to video conditions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 6 months | Blood pressure was measured using automated sphygmomanometer based on standardized protocols. |
| Diastolic Blood Pressure | 6 months | Blood pressure was measured using automated sphygmomanometer based on standardized protocols. |
| PROMIS - Mental Health | 6 months | Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life. |
| PROMIS - Physical Health | 6 months | Health-related quality of life was measured with the PROMIS Global Scale. This 10-item measured the overall physical, mental, and social health of adults. Items range from (1 = never to 5 = always) on a Likert-type scale. Higher scores indicate better quality of life. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.04 years STANDARD_DEVIATION 7.6 |
| Brain Activity | 0.09 Values reflect % change in BOLD response STANDARD_DEVIATION 0.42 |
| Diastolic Blood Pressure | 86.76 mm Hg STANDARD_DEVIATION 9.21 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| PROMIS - Mental Health | 3.16 scores on a scale STANDARD_DEVIATION 0.69 |
| PROMIS - Physical Health | 3.18 scores on a scale STANDARD_DEVIATION 0.48 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 25 Participants |
| Sex: Female, Male Male | 0 Participants |
| Systolic Blood Pressure | 132.56 mm Hg STANDARD_DEVIATION 17.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
None listed