Uncontrolled Hypertension
Conditions
Keywords
hypertension, Black women, self-management, coaching
Brief summary
Hypertension (HTN) is a global problem affecting 972 million adults and an important public health burden since it is the main cause of cardiovascular disease and death, and the second leading cause of disability. Disproportionately affected, Black women have the highest prevalence of HTN in the United States. This research will evaluate potential interventions for possible community-based strategies for controlling HTN using interactive self-care strategies with coaching and technology. We hypothesize that participants who receive the Chronic Disease Self-Management Program (CDSMP) workshop and Interactive Technology Enhanced Coaching (ITEC) will have lower systolic/diastolic blood pressure (BP) and better adherence to antihypertensive medication(s) and lifestyle recommendations (physical activity, diet, and weight management) post intervention compared to participants receiving self-care management alone.
Detailed description
This study includes a sample of community dwelling Black women with uncontrolled HTN. All participants meeting study eligibility requirements will receive the Chronic Disease Self-Management Program (CDSMP) workshop for 6 weeks. Participants from this pool will be randomized to the treatment and control arm. All study participants will continue to receive usual care for their HTN. The intervention will be divided into three steps. At Step 1 for 3 months, the treatment arm will receive electronic monitoring (of participants' BP, weight, physical activity, food diary, and medication-taking) with weekly Interactive Technology Enhanced Coaching (ITEC) while the control arm will receive usual care with manual BP measurements monthly. At Step 2 for three months, the treatment arm will receive electronic monitoring with ITEC biweekly, and the control arm will receive electronic monitoring only. At Step 3 for three months, both the treatment arm and the control arm will receive electronic monitoring only. Our sample of n=45 participants per arm (N=90 in total), will be measured (electronic measurements, anthropometric measurements, and data collection tools) at baseline, 3 months, 6 months, and at 9 months post CDSMP. A hierarchical, mixed-effects repeated measures design will be used to analyze the data. The project is a two-arm randomized controlled trial with specific aims to determine whether the effects of CDSMP combined with ITEC will maintain BP control, attain medication adherence, and achieve lifestyle modifications (physical activity, diet, and weight management) compared to the CDSMP alone. We will test the hypothesis that: 1. More participants in the CDSMP/ITEC arm will have controlled BP less than 130/80 at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in CDSMP alone. 2. More participants in the CDSMP/ITEC arm will have higher levels of adherence to antihypertensive medication(s) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone. 3. More participants in the CDSMP/ITEC arm, will have higher levels of adherence to lifestyle modifications (physical activity, diet, and weight management) at 3 months, 6 months, and at 9 months post CDSMP, compared to participants in the CDSMP alone. Information from this study may be used to enhance self-care management, control blood pressure, and increase the quality of life for Black women who are burdened with the adverse effects of HTN and its high disability and mortality rates.
Interventions
BEHAVIORALInteractive Technology Enhanced Coaching (ITEC)
As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Staff monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
BEHAVIORALInteractive Technology-No Coaching (IT)
After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the CDSMP workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of North Carolina, Charlotte
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will test the effects of ITEC added to CDSMP on two study aims: 1) BP control, and 2) adherence to antihypertensive medication and lifestyle modifications. After baseline data collection, participants complete a 6-week CDSMP course and then are randomly assigned to either the treatment or control arm. All participants will continue to receive usual care for HTN. The treatment group will receive ITEC and wireless tools to track activity, BP, weight, food intake, and self-report medication-taking after an orientation to Fitbit Plus (a cloud-based collaborative care platform designed to store and track data). All tools will be synced to the participants' smartphone. The treatment arm will receive weekly ITEC for 3 months, biweekly ITEC for 3 months, and then no ITEC for 3 months. The control arm will receive usual care only with monthly BP measured manually for 3 months and then receive the same wireless tools with monitoring to track comparative data with the treatment arm.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Self-identified as Black or African American; * 18-70 years of age * English speaking * Has to live in the study community, Charlotte or surrounding area * Systolic BP greater than or equal to 130 and/or diastolic BP greater than or equal to 80 at screening * Prescribed to take one or more antihypertensive medication(s) * Smartphone or device * Bluetooth 4.0 and Provider network or Wi-Fi connectivity
Exclusion criteria
* Self-report of mental illness that interferes with daily functioning * Unable to be physically active * Current pregnancy * Plans to move from the study area during the project * Systolic BP greater than or equal to 160 and/or diastolic BP greater than or equal to 100 * Uncontrolled diabetes (HbA1c \>8.5), hemodialysis, stroke (within past year with residual effects such as weakness, paralysis, speech difficulty, etc.), cancer treatment (for spread of cancer to other places in the body), or a heart attack (within the past year) * Concurrent participation in another research study and/or taken any Stanford self-management program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure (BP) | Baseline to 3 months, 6 months, and 9 months. | To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence by Proportion of Days Covered | Month 1 to Month 3, Month 6, and Month 9. | To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100. |
| Physical Activity (Change in Daily Steps) | Month 1 to Month 3, Month 6, and Month 9. | To show the change (increase) in daily steps over 9 months. |
| Change in Weight | Baseline to 3 months, 6 months, and 9 months. | To show the change (decrease) in weight over 9 months. |
| Change in Dietary Intake (Sodium) | Month 1 to Month 3, Month 6, and Month 9. | To show the change (decrease) in dietary intake (sodium) over 9 months. |
| Change in Dietary Intake (Calories) | Month 1 to Month 3, Month 6, and Month 9. | To show the change (decrease) in dietary intake (calories) over 9 months. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Stigma and Hypertension, Qualitative Study | 15 minutes | Qualitative questionnaire (included written responses to two open-ended questions) to gain insight and describe the psychological factor of stigma as an influence on poorly controlled hypertension in Black women. No scale was used to assess data. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from areas frequented by Black women, including churches, sororities, clubs, community associations, neighborhood schools, and community events between January 2019 and April 2019. The first participant was enrolled on January 28, 2019, and the last participant was enrolled on April 13, 2019.
Pre-assignment details
Of the 166 individuals approached for enrollment, 40 did not meet the inclusion criteria, 36 declined to participate, while 90 met the inclusion criteria and consented to participate in the study. The 90 participants were enrolled in the 6-week Chronic Disease Self-Management Program (CDSMP), and 83 completed the program and were randomized to treatment. Of the 83 participants, 77 had Fitbit data for analysis.
Participants by arm
| Arm | Count |
|---|---|
| Interactive Technology Enhanced Coaching (ITEC) Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale, along with coaching by means of personalized text messages.
Data were collected and compared at 3, 6, and 9 months. | 42 |
| Interactive Technology-No Coaching (IT) Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale.
Data were collected and compared at 3, 6, and 9 months. | 41 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 6 |
| Overall Study | Withdrawal by Subject | 4 | 7 |
Baseline characteristics
| Characteristic | Interactive Technology-No Coaching (IT) | Total | Interactive Technology Enhanced Coaching (ITEC) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 12 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants | 71 Participants | 36 Participants |
| Age, Continuous | 52.7 years STANDARD_DEVIATION 11 | 54.1 years STANDARD_DEVIATION 9.9 | 55.6 years STANDARD_DEVIATION 8.6 |
| Baseline diastolic blood pressure | 84.3 mmHg STANDARD_DEVIATION 7 | 84.1 mmHg STANDARD_DEVIATION 7.8 | 83.9 mmHg STANDARD_DEVIATION 8.6 |
| Baseline systolic blood pressure | 139.0 mmHg STANDARD_DEVIATION 9 | 139.6 mmHg STANDARD_DEVIATION 10 | 140.1 mmHg STANDARD_DEVIATION 11 |
| Baseline weight | 214.3 pounds STANDARD_DEVIATION 52.2 | 213.9 pounds STANDARD_DEVIATION 49.7 | 213.5 pounds STANDARD_DEVIATION 47.2 |
| Education Completed 4-year college | 10 Participants | 28 Participants | 18 Participants |
| Education Completed community college | 4 Participants | 7 Participants | 3 Participants |
| Education Completed graduate school | 14 Participants | 24 Participants | 10 Participants |
| Education Completed high school | 2 Participants | 2 Participants | 0 Participants |
| Education Less than 12th grade | 1 Participants | 1 Participants | 0 Participants |
| Education Some 4-year college | 5 Participants | 8 Participants | 3 Participants |
| Education Some community college | 4 Participants | 11 Participants | 7 Participants |
| Education Some graduate school | 1 Participants | 2 Participants | 1 Participants |
| Income <10,000 - 24,999 | 5 Participants | 11 Participants | 6 Participants |
| Income 25,000 - 54,999 | 12 Participants | 26 Participants | 14 Participants |
| Income 55,000 - >100,000 | 23 Participants | 44 Participants | 21 Participants |
| Income Refused | 1 Participants | 2 Participants | 1 Participants |
| Marital Status Married | 18 Participants | 36 Participants | 18 Participants |
| Marital Status Separated/Divorced | 9 Participants | 21 Participants | 12 Participants |
| Marital Status Single (never married) | 12 Participants | 22 Participants | 10 Participants |
| Marital Status Widowed | 2 Participants | 4 Participants | 2 Participants |
| Occupational Status Retired with pension | 5 Participants | 13 Participants | 8 Participants |
| Occupational Status Work full-time | 33 Participants | 60 Participants | 27 Participants |
| Occupational Status Work part-time / Not employed | 3 Participants | 10 Participants | 7 Participants |
| 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 | 41 Participants | 83 Participants | 42 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 | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 41 participants | 83 participants | 42 participants |
| Sex: Female, Male Female | 41 Participants | 83 Participants | 42 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Years with Hypertension | 9.8 years STANDARD_DEVIATION 8 | 10.4 years STANDARD_DEVIATION 8 | 11.0 years STANDARD_DEVIATION 8.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 41 |
| other Total, other adverse events | 0 / 42 | 0 / 41 |
| serious Total, serious adverse events | 9 / 42 | 3 / 41 |
Outcome results
Primary
Change in Systolic and Diastolic Blood Pressure (BP)
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
Time frame: Baseline to 3 months, 6 months, and 9 months.
Population: Numbers may have decreased over time due to attrition and/or non-participation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Baseline Systolic BP | 140.07 mmHg | Standard Error 1.5781 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 3 Systolic BP | 124.18 mmHg | Standard Error 1.9429 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 6 Systolic BP | 125.80 mmHg | Standard Error 1.9606 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 9 Systolic BP | 125.04 mmHg | Standard Error 1.7349 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Baseline Diastolic BP | 83.8578 mmHg | Standard Error 1.2306 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 3 Diastolic BP | 82.8319 mmHg | Standard Error 1.4629 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 6 Diastolic BP | 83.2099 mmHg | Standard Error 1.3628 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 9 Diastolic BP | 82.5838 mmHg | Standard Error 1.4368 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 9 Diastolic BP | 81.6017 mmHg | Standard Error 1.5639 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Baseline Systolic BP | 139.03 mmHg | Standard Error 1.6841 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Baseline Diastolic BP | 84.3161 mmHg | Standard Error 1.3132 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 3 Systolic BP | 128.31 mmHg | Standard Error 1.9737 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 6 Diastolic BP | 82.3126 mmHg | Standard Error 1.4482 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 6 Systolic BP | 126.13 mmHg | Standard Error 2.0827 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 3 Diastolic BP | 79.9767 mmHg | Standard Error 1.4749 |
| Interactive Technology-No Coaching (IT) | Change in Systolic and Diastolic Blood Pressure (BP) | Month 9 Systolic BP | 125.67 mmHg | Standard Error 1.8618 |
Secondary
Change in Dietary Intake (Calories)
To show the change (decrease) in dietary intake (calories) over 9 months.
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Calories) | Month 1 Calories | 1204.75 calories | Standard Error 81.7083 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Calories) | Month 3 Calories | 1133.66 calories | Standard Error 92.0513 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Calories) | Month 6 Calories | 801.42 calories | Standard Error 96.877 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Calories) | Month 9 Calories | 1247.33 calories | Standard Error 146.01 |
| Interactive Technology-No Coaching (IT) | Change in Dietary Intake (Calories) | Month 6 Calories | 803.38 calories | Standard Error 122.88 |
| Interactive Technology-No Coaching (IT) | Change in Dietary Intake (Calories) | Month 9 Calories | 1029.74 calories | Standard Error 165.78 |
p-value: 0.05mixed-effects repeated measures
Secondary
Change in Dietary Intake (Sodium)
To show the change (decrease) in dietary intake (sodium) over 9 months.
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Sodium) | Month 9 Sodium | 1226.89 mg | Standard Error 179.26 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Sodium) | Month 3 Sodium | 1386.61 mg | Standard Error 134.26 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Sodium) | Month 6 Sodium | 775.66 mg | Standard Error 141.33 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Dietary Intake (Sodium) | Month 1 Sodium | 1363.65 mg | Standard Error 116.66 |
| Interactive Technology-No Coaching (IT) | Change in Dietary Intake (Sodium) | Month 6 Sodium | 928.30 mg | Standard Error 181.33 |
| Interactive Technology-No Coaching (IT) | Change in Dietary Intake (Sodium) | Month 9 Sodium | 1512.05 mg | Standard Error 241.61 |
p-value: 0.05mixed-effects repeated measures
Secondary
Change in Weight
To show the change (decrease) in weight over 9 months.
Time frame: Baseline to 3 months, 6 months, and 9 months.
Population: Numbers may have decreased over time due to attrition and/or non-participation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Change in Weight | Baseline Weight | 213.54 pounds | Standard Error 7.639 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Weight | Month 3 Weight | 205.23 pounds | Standard Error 7.6767 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Weight | Month 9 Weight | 202.36 pounds | Standard Error 7.8919 |
| Interactive Technology Enhanced Coaching (ITEC) | Change in Weight | Month 6 Weight | 203.71 pounds | Standard Error 7.7075 |
| Interactive Technology-No Coaching (IT) | Change in Weight | Month 6 Weight | 203.71 pounds | Standard Error 8.2126 |
| Interactive Technology-No Coaching (IT) | Change in Weight | Baseline Weight | 214.31 pounds | Standard Error 8.1523 |
| Interactive Technology-No Coaching (IT) | Change in Weight | Month 9 Weight | 205.40 pounds | Standard Error 8.4171 |
| Interactive Technology-No Coaching (IT) | Change in Weight | Month 3 Weight | 212.20 pounds | Standard Error 8.1523 |
Secondary
Medication Adherence by Proportion of Days Covered
To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100.
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Medication Adherence by Proportion of Days Covered | Month 1 Med Adherence | 0.7404 Proportion of days | Standard Error 0.06353 |
| Interactive Technology Enhanced Coaching (ITEC) | Medication Adherence by Proportion of Days Covered | Month 3 Med Adherence | 0.6507 Proportion of days | Standard Error 0.06353 |
| Interactive Technology Enhanced Coaching (ITEC) | Medication Adherence by Proportion of Days Covered | Month 6 Med Adherence | 0.5575 Proportion of days | Standard Error 0.06353 |
| Interactive Technology Enhanced Coaching (ITEC) | Medication Adherence by Proportion of Days Covered | Month 9 Med Adherence | 0.6507 Proportion of days | Standard Error 0.06353 |
| Interactive Technology-No Coaching (IT) | Medication Adherence by Proportion of Days Covered | Month 6 Med Adherence | 0.5357 Proportion of days | Standard Error 0.06779 |
| Interactive Technology-No Coaching (IT) | Medication Adherence by Proportion of Days Covered | Month 9 Med Adherence | 0.5595 Proportion of days | Standard Error 0.06779 |
p-value: 0.05mixed-effects repeated measures
Secondary
Physical Activity (Change in Daily Steps)
To show the change (increase) in daily steps over 9 months.
Time frame: Month 1 to Month 3, Month 6, and Month 9.
Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Interactive Technology Enhanced Coaching (ITEC) | Physical Activity (Change in Daily Steps) | Month 1 Steps | 5778.58 steps | Standard Error 555.38 |
| Interactive Technology Enhanced Coaching (ITEC) | Physical Activity (Change in Daily Steps) | Month 3 Steps | 5384.34 steps | Standard Error 593.17 |
| Interactive Technology Enhanced Coaching (ITEC) | Physical Activity (Change in Daily Steps) | Month 6 Steps | 4720.90 steps | Standard Error 611.08 |
| Interactive Technology Enhanced Coaching (ITEC) | Physical Activity (Change in Daily Steps) | Month 9 Steps | 4743.20 steps | Standard Error 770.29 |
| Interactive Technology-No Coaching (IT) | Physical Activity (Change in Daily Steps) | Month 6 Steps | 6413.73 steps | Standard Error 663.43 |
| Interactive Technology-No Coaching (IT) | Physical Activity (Change in Daily Steps) | Month 9 Steps | 5092.30 steps | Standard Error 798.81 |
p-value: 0.05mixed-effects repeated measures
Other Pre-specified
Stigma and Hypertension, Qualitative Study
Qualitative questionnaire (included written responses to two open-ended questions) to gain insight and describe the psychological factor of stigma as an influence on poorly controlled hypertension in Black women. No scale was used to assess data.
Time frame: 15 minutes