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Stress/Emotion Management for High Blood Pressure (OUR-Project Trial)
N/A
Waitlist Available
Led By Kathy D Wright, PhD, RN
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Female sex
Be older than 18 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a synchronous web-based version of Enhanced Co-Created Health Education InterventioN (eCo-CHIN) to help Black women with hypertension manage stress and emotional well-being in a social-distancing society.
Who is the study for?
This trial is for Black/African American women who have high blood pressure, can speak English, and have access to a smartphone or computer with internet. It's not for those with resistant hypertension (blood pressure too high despite using three different meds including a diuretic) or without internet access.
What is being tested?
The study tests an online stress and emotion management program called eCo-CHIN, designed specifically for Black women managing hypertension during the Covid-19 pandemic. It includes sessions on resilience and self-care in times of social distancing.
What are the potential side effects?
Since this intervention involves stress management techniques rather than medication, there are no direct medical side effects. However, participants may experience emotional discomfort while discussing personal experiences related to stress.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am female.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My high blood pressure isn't controlled despite taking three different blood pressure medicines, including a water pill.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline at 3 months blood pressure.
Change from baseline at 3 months waist circumference.
Change from baseline at 3 months weight.
+2 moreSecondary study objectives
Change from baseline dietary approaches to stop hypertension knowledge at 3 months.
Change from baseline emotional regulation at 3 months.
Change from baseline resilience at 3 months.
+2 moreOther study objectives
Explore the feasibility of collecting cognitive performance data (processing speed, attention, and executive function) via teleconference.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Stress and emotion Management for Black/African AmericExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Ohio State UniversityLead Sponsor
870 Previous Clinical Trials
655,026 Total Patients Enrolled
Kathy D Wright, PhD, RNPrincipal InvestigatorAssistant Professor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have high blood pressure and am managing it with medication or lifestyle changes.My high blood pressure isn't controlled despite taking three different blood pressure medicines, including a water pill.You consider yourself to be Black or African American.I am female.
Research Study Groups:
This trial has the following groups:- Group 1: Stress and emotion Management for Black/African Americ
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.