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

Stress, Psychological Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04526145
• Other study ID #: 2020B0182
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: May 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Stress, Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.	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.	baseline and 3 months
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.	4 weeks
Primary	Determine the acceptability of a synchronous web-based health education program, of OUR project.	Investigator generated open-ended questions.	1 month
Primary	Change from baseline at 3 months weight.	Weight measured in pounds.	Baseline to 3 months
Primary	Change from baseline at 3 months waist circumference.	Waist circumference measured in inches.	Baseline to 3 months
Primary	Change from baseline at 3 months blood pressure.	Self-blood pressure collection using an automatic home blood pressure monitor systolic and diastolic in mmHg	Baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	baseline to 3 months
Secondary	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.	Baseline