Stress, Psychological
Conditions
Keywords
hypertension, Covid-19, Black and African American women, Mindfulness, Diet
Brief summary
Covid-19 is an additional stressor Black women have to deal with that may interfere with hypertension self-care management. Social connectedness is a source of resilience for Black women to promote mental and physical health. Unfortunately, in the face of the Covid-19 pandemic, social distancing is a challenge further isolating Black women from their networks. How is social connectedness to manage stress and emotional well-being in a social-distancing society for Black women with hypertension? The research team proposed a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) that build the success and best practices derived from the original intervention. A Covid-19 session will be included as a way of helping Black women to maintain resilience and self-care during stressful times. The eCo-CHIN intervention is innovative and timely because the research team are using a synchronous platform preparing Black women on how to deal with Covid-19 while taking care of self. The primary investigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator and former KL2 (career development) awardee. The interdisciplinary research team has the expertise and resources to deliver this Enhanced Co-CHIN intervention.
Detailed description
The rationale for the study is that the adherence to healthy self-care behaviors reduces poor nutrition, altered sleep, sedentary behavior, psychosocial stress, and emotional dysregulation, thereby reducing negative impacts on the brain, since all these factors contribute to neural inflammation and increased BP. Health-promoting self-care behaviors have the known short-term effect of enhanced cognitive function (processing speed, attention, and executive function) through the use of The Repeatable Neuropsychiatric Battery (RBANS) which is also an innovative component of OUR Project. Thirty middle-aged Black women (45-65 years old) with a self-reported diagnosis of hypertension will be enrolled. The development of this group-delivered intervention will be an iterative process, and the research team will use this pilot data to submit an R21 for a 12-week intervention through the National Institutes on Aging.
Interventions
BEHAVIORALStress and emotion management
Group intervention led by a nurse and dietitian to address stress, emotion management and healthy lifestyle for African American women with hypertension. The weekly sessions will include:how to manage stress during Covid-19, taking blood pressure, interpersonal relationships skills, mindful awareness, restful sleep, physical activity, and healthy eating.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* English speaking, * self-identification as Black/African America * diagnosis of hypertension (treated with medications and or lifestyle management) * female sex * access to a smart phone or a computer capable of connecting to the Internet
Exclusion criteria
* no access to computer with internet Smart phone * diagnosis of resistant hypertension defined as blood pressure that remains above goal despite concurrent use of three antihypertensive agents of different classes, one of which should be a diuretic/water pill.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Feasibility of a Synchronous Web-based Health Education Program, of OUR Project. | 4 weeks | Weekly participant attendance will be recorded as date, month and year. |
| Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project. | 1 month and 6 months post intervention | Investigator generated questions regarding the acceptability of the program. There are 13 questions ranked on a 10 point scale, with higher scores indicating a stronger acceptability of the program. Total scores range from 13 to 130 for each individual. All scores are averaged. |
| Change From Baseline at 1 Month Weight. | Baseline to 1 month post baseline | Weight measured in pounds. |
| Change From Baseline at 1 Month Waist Circumference. | Baseline to 1 month post baseline | Waist circumference measured in inches. |
| Change From Baseline at 1 Month Systolic Blood Pressure. | Baseline to 1 month baseline | Self-blood pressure collection using an automatic home blood pressure monitor systolic blood pressure in mmHg |
| Change From Baseline at 1 Month Diastolic Blood Pressure. | Baseline to 1 month baseline | Self-blood pressure collection using an automatic home blood pressure monitor diastolic blood pressure in mmHg |
Countries
United States
Participant flow
Pre-assignment details
2 Consented individuals did not begin the study due to a change in eligibility prior to beginning of study.
Participants by arm
| Arm | Count |
|---|---|
| Stress and Emotion Management for Black/African Americ Four weekly sessions delivered in a group format via Zoom teleconference. The following topics are listed in the workbook: Planning Your Information Diet; My Spheres of Influence Worksheet; Practical Wisdom for Tolerating Uncertainty; Reducing Anxiety With Thought Challenging; Reducing Anxiety Through Distraction Activities; Starting a Planning Practice; Starting a Daily Gratitude Practice; Starting a Daily Breathing Practice; Improving the Quality of Your Social Connections; Developing a Regular Exercise Routine; and Creating Your Stress-Resilience Action Plan. Each session will begin with a 15-30 minute check in on what went well, challenges, and Coronavirus Anxiety workbook. The Coronavirus Anxiety Workbook topics are complementary and the sessions will tie together the themes of comprehensive stress and emotional management through blood pressure knowledge/self-monitoring, diet, interpersonal communication skills building, and sleep hygiene.
Stress and emotion management: Group intervention led by a nurse and dietitian to address stress, emotion management and healthy lifestyle for African American women with hypertension. The weekly sessions will include:how to manage stress during Covid-19, taking blood pressure, interpersonal relationships skills, mindful awareness, restful sleep, physical activity, and healthy eating. | 14 |
| Total | 14 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Stress and Emotion Management for Black/African Americ |
|---|---|
| Age, Customized 47-53 | 5 Participants |
| Age, Customized 54+ | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 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 |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
| Years of Education 0-6 | 0 Participants |
| Years of Education 10+ | 14 Participants |
| Years of Education 7-9 | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 16 |
| other Total, other adverse events | 0 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Change From Baseline at 1 Month Diastolic Blood Pressure.
Self-blood pressure collection using an automatic home blood pressure monitor diastolic blood pressure in mmHg
Time frame: Baseline to 1 month baseline
Population: 1 participant did not have blood pressure measured at baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Diastolic Blood Pressure. | Baseline | 87.0 mmHg | Standard Deviation 10.3 |
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Diastolic Blood Pressure. | Post 1-Month | 83.4 mmHg | Standard Deviation 4.6 |
Primary
Change From Baseline at 1 Month Systolic Blood Pressure.
Self-blood pressure collection using an automatic home blood pressure monitor systolic blood pressure in mmHg
Time frame: Baseline to 1 month baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Systolic Blood Pressure. | Baseline | 128.5 mmHg | Standard Deviation 17.4 |
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Systolic Blood Pressure. | Post 1-Month | 122.5 mmHg | Standard Deviation 16.2 |
Primary
Change From Baseline at 1 Month Waist Circumference.
Waist circumference measured in inches.
Time frame: Baseline to 1 month post baseline
Population: 1 participant did not have waist circumference measured at baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Waist Circumference. | Baseline | 44.5 inches | Standard Deviation 5 |
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Waist Circumference. | Post 1-Month | 45.9 inches | Standard Deviation 6.9 |
Primary
Change From Baseline at 1 Month Weight.
Weight measured in pounds.
Time frame: Baseline to 1 month post baseline
Population: 5 participants were lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Weight. | Baseline | 234.3 pounds | Standard Deviation 47.4 |
| Stress and Emotion Management for Black/African Americ | Change From Baseline at 1 Month Weight. | Post -1 Month | 250.8 pounds | Standard Deviation 50.9 |
Primary
Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project.
Investigator generated questions regarding the acceptability of the program. There are 13 questions ranked on a 10 point scale, with higher scores indicating a stronger acceptability of the program. Total scores range from 13 to 130 for each individual. All scores are averaged.
Time frame: 1 month and 6 months post intervention
Population: Some participants did not participate in the intervention acceptability testing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project. | 1 month post intervention | 98.6 score on a scale | Standard Deviation 10.1 |
| Stress and Emotion Management for Black/African Americ | Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project. | 6 months post intervention | 96.1 score on a scale | Standard Deviation 14.4 |
Primary
Determine the Feasibility of a Synchronous Web-based Health Education Program, of OUR Project.
Weekly participant attendance will be recorded as date, month and year.
Time frame: 4 weeks
Population: 4 weekly sessions, attendance at each session was measured
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stress and Emotion Management for Black/African Americ | Determine the Feasibility of a Synchronous Web-based Health Education Program, of OUR Project. | 2.93 weeks attendance/month | Standard Deviation 1.21 |