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

NCT04526145 | Completed Results

• 1 other identifier: 2020B0182
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Keywords

hypertension; Covid-19; Black and African American women; Mindfulness; Diet

Outcome Measures

Primary Outcomes (6)

• 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

• 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.

  1 month and 6 months post intervention

• Change From Baseline at 1 Month Weight.

  Weight measured in pounds.

  Baseline to 1 month post baseline

• Change From Baseline at 1 Month Waist Circumference.

  Waist circumference measured in inches.

  Baseline to 1 month post baseline

• 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

  Baseline to 1 month baseline

• 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

  Baseline to 1 month baseline

Study Arms (1)

Stress and emotion Management for Black/African Americ

EXPERIMENTAL

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.

Behavioral: Stress and emotion management

Interventions

Stress and emotion management BEHAVIORAL

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.

Stress and emotion Management for Black/African Americ

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Self-report of female sex at birth.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Stress, Psychological; Hypertension; COVID-19

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Vascular Diseases; Cardiovascular Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr. Kathy Wright
• Organization: Ohio State University

wright.2104@osu.edu

614-292-0309

Study Officials

• Kathy D Wright, PhD, RN

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 25, 2020
• Study Start: May 1, 2021
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 16, 2025
• Results First Posted: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)