Clinical trial NCT04526145: OUR Stress/ Emotion Management for Black/African American Women With Hypertension
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
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological
Keywords: hypertension
Covid-19
Black and African American women
Mindfulness
Diet
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 16
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Determine the Feasibility of a Synchronous Web-based Health Education Program, of OUR Project.
timeFrame: 4 weeks
measure: Determine the Acceptability of a Synchronous Web-based Health Education Program, of OUR Project.
timeFrame: 1 month and 6 months post intervention
measure: Change From Baseline at 1 Month Weight.
timeFrame: Baseline to 1 month post baseline
measure: Change From Baseline at 1 Month Waist Circumference.
timeFrame: Baseline to 1 month post baseline
measure: Change From Baseline at 1 Month Systolic Blood Pressure.
timeFrame: Baseline to 1 month baseline
measure: Change From Baseline at 1 Month Diastolic Blood Pressure.
timeFrame: Baseline to 1 month baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Assistant Professor
name: Kathy D Wright, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: