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OUR Stress/ Emotion Management for Black/African American Women With Hypertension (OUR-Project)

Primary Purpose

Stress, Psychological

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stress and emotion management
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stress, Psychological focused on measuring hypertension, Covid-19, Black and African American women, Mindfulness, Diet

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stress and emotion Management for Black/African Americ

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Determine the acceptability of a synchronous web-based health education program, of OUR project.
Investigator generated open-ended questions.
Change from baseline at 3 months weight.
Weight measured in pounds.
Change from baseline at 3 months waist circumference.
Waist circumference measured in inches.
Change from baseline at 3 months blood pressure.
Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg

Secondary Outcome Measures

Change from baseline stress at 3 months.
Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past month with higher scores indicating higher levels of stress. Ranges 0-30.
Change from baseline emotional regulation at 3 months.
Difficulties in Emotion Regulation Scale. This measure has 18 items, each measured on a 5-point rating scale. One total score will calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.
Change from baseline dietary approaches to stop hypertension knowledge at 3 months.
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q). The DASH Q had 15 items eliciting responses regarding the consumption of DASH diet foods (e.g., fruits, nuts, and vegetables) in the past seven days. Higher score indicates greater DASH knowledge. Range 0-105.
Change from baseline resilience at 3 months.
The Brief Resilience Scale contains 5 questions on a Likert type scale assessing the ability to "bounce back" from stressors. Scores will be summed and higher scores indicate higher resilience.
Describe participant experience and health during the COVID-19 pandemic.
All of Us Program COVID-19 COPE Survey contains items that are not scored on a summary scale, that include social distancing experiences, COVID-19 related symptoms, and COVID-19 related treatment. Descriptive statistics will be used to summarize participant's experiences.

Full Information

First Posted
August 10, 2020
Last Updated
June 9, 2023
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04526145
Brief Title
OUR Stress/ Emotion Management for Black/African American Women With Hypertension
Acronym
OUR-Project
Official Title
Operating Under Resilience (OUR) Project: Stress and Emotion Management for Black/African American Women With Hypertension In a Covid--19 Social Distancing Society
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 30, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological
Keywords
hypertension, Covid-19, Black and African American women, Mindfulness, Diet

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stress and emotion Management for Black/African Americ
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Stress and emotion management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determine the feasibility of a synchronous web-based health education program, of OUR project.
Description
Weekly participant attendance will be recorded as date, month and year.
Time Frame
4 weeks
Title
Determine the acceptability of a synchronous web-based health education program, of OUR project.
Description
Investigator generated open-ended questions.
Time Frame
1 month
Title
Change from baseline at 3 months weight.
Description
Weight measured in pounds.
Time Frame
Baseline to 3 months
Title
Change from baseline at 3 months waist circumference.
Description
Waist circumference measured in inches.
Time Frame
Baseline to 3 months
Title
Change from baseline at 3 months blood pressure.
Description
Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Change from baseline stress at 3 months.
Description
Perceived Stress Scale is a 10-item Likert scale questionnaire regarding stress over the past month with higher scores indicating higher levels of stress. Ranges 0-30.
Time Frame
baseline to 3 months
Title
Change from baseline emotional regulation at 3 months.
Description
Difficulties in Emotion Regulation Scale. This measure has 18 items, each measured on a 5-point rating scale. One total score will calculated by summing the individual item responses. Higher scores represent greater perceived difficulties in emotion regulation capabilities.
Time Frame
baseline to 3 months
Title
Change from baseline dietary approaches to stop hypertension knowledge at 3 months.
Description
Dietary Approaches to Stop Hypertension Questionnaire (DASH-Q). The DASH Q had 15 items eliciting responses regarding the consumption of DASH diet foods (e.g., fruits, nuts, and vegetables) in the past seven days. Higher score indicates greater DASH knowledge. Range 0-105.
Time Frame
baseline to 3 months
Title
Change from baseline resilience at 3 months.
Description
The Brief Resilience Scale contains 5 questions on a Likert type scale assessing the ability to "bounce back" from stressors. Scores will be summed and higher scores indicate higher resilience.
Time Frame
baseline to 3 months
Title
Describe participant experience and health during the COVID-19 pandemic.
Description
All of Us Program COVID-19 COPE Survey contains items that are not scored on a summary scale, that include social distancing experiences, COVID-19 related symptoms, and COVID-19 related treatment. Descriptive statistics will be used to summarize participant's experiences.
Time Frame
Baseline
Other Pre-specified Outcome Measures:
Title
Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.
Description
The Repeatable Neuropsychiatric Battery (RBANS) will be collected. The RBANS consists of 12 subtests that assess cognitive domains such as Immediate and Delayed Memory, Language, Attention, and Visuospatial/Construction and takes about 30 minutes to administer. A total RBANS sum of index scores will be computed by age.
Time Frame
baseline and 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Self-report of female sex at birth.
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy D Wright, PhD, RN
Organizational Affiliation
Assistant Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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OUR Stress/ Emotion Management for Black/African American Women With Hypertension

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