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Completed

NCT Number: NCT04526145

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

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.

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Key information

Conditions

Stress, Psychological Behavior Behavioral Symptoms COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Hypertension Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Determine the Feasibility of a Synchronous Web-based Health Education Program, of OUR Project.

    Time frame: 4 weeks

    Weekly participant attendance will be recorded as date, month and year.

  2. Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project.

    Time frame: 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.

  3. Change From Baseline at 1 Month Weight.

    Time frame: Baseline to 1 month post baseline

    Weight measured in pounds.

  4. Change From Baseline at 1 Month Waist Circumference.

    Time frame: Baseline to 1 month post baseline

    Waist circumference measured in inches.

  5. Change From Baseline at 1 Month Systolic Blood Pressure.

    Time frame: Baseline to 1 month baseline

    Self-blood pressure collection using an automatic home blood pressure monitor systolic blood pressure in mmHg

  6. Change From Baseline at 1 Month Diastolic Blood Pressure.

    Time frame: Baseline to 1 month baseline

    Self-blood pressure collection using an automatic home blood pressure monitor diastolic blood pressure in mmHg

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Operating Under Resilience (OUR) Project: Stress and Emotion Management for Black/African American Women With Hypertension In a Covid--19 Social Distancing Society

Acronym: OUR-Project

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Aug 25, 2020
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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