- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05308914
Self-Management and Resilience Trajectories in African American Adults With Hypertension
Hypertension (HTN) rates have increased worldwide, but the most significant increase in the incidence of morbidity and mortality has been in African Americans (AA)1,2 (43% vs 27% for other U.S. population groups). Despite evidence of positive benefits from lifestyle modification (healthy diet, reduced sodium intake, increased physical activity, smoking cessation) and prescribed antihypertensive therapy (AHT) many AA with HTN do not adhere to their treatment regimens. Consistent, effective lifelong self-management is required to sustain optimal BP control and thus reduce morbidity and mortality. Self-managing HTN to a blood pressure (BP) <130/80 mm Hg presents challenges such as juggling multiple medications and health care providers, dealing with complex recommendations and treatment regimens, and coping with negative emotional states. Few studies have examined the biopsychosocial mechanisms that foster effective HTN self-management and resilience among AA living with HTN. Understanding the mechanisms that influence HTN self-management and resilience in AA holds the promise of new modifiable targets for behavior-change interventions.
This study explores the relationship among resilience precursors on hypertension (HTN) self-management behaviors, stress response, and the effects that these relationships have on health outcomes-health-related quality of life (HRQOL) and blood pressure (BP) in African Americans (AA) with HTN over a 6-month period.
Study Overview
Status
Detailed Description
This study identifies profiles of self-management and the resilience trajectories in AA with HTN can lead to culturally appropriate, patient-centered interventions that improve their HTN self-management, quality of life, and long-term compliance.
This study aims to:
- Assess the association among resilience precursors (dispositional optimism and resilience, emotion regulation); stress response (physiological: cortisol, interleukins [IL-6] and psychological: depression cognitions, perceived stress); hypertension self management behaviors (self-efficacy for chronic disease management, medication adherence to antihypertensives); and health outcomes (HQROL and BP) in AA with HTN at baseline and months 3 and 6.
- Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Identify resilience trajectory patterns and factors that influence HTN self-management behaviors over time.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carolyn H Still, PhD
- Phone Number: 216-368-6338
- Email: carolyn.still@case.edu
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Recruiting
- University Hospitals Cleveland Medical Center
-
Contact:
- Carolyn H Still, PhD
- Phone Number: 216-844-3798
- Email: carolyn.still@uhhospitals.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Self-identify as African American
- 25 years of age or older
- Diagnosed with hypertension and prescribed one antihypertensive medication
- BP >130/80 mmHg
- Have at least one additional chronic health conditions
- Able to read/understand English
Exclusion Criteria:
- Unable to give informed consent or judged to have impaired cognitive ability or severe memory
- Have experienced a major CVD event or procedure (e.g., myocardial infarction, stroke, heart surgery) within the past year
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Resilience Study Cohort
Observational, descriptive longitudinal cohort design.
See inclusion and exclusion criteria for more information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
systolic and diastolic Blood Pressure
Time Frame: Baseline - 6 months
|
Measure of participants' in clinic blood pressure (average of three blood pressure readings).
|
Baseline - 6 months
|
PROMIS Global Health-10 [health-related quality of life]
Time Frame: Baseline - 6 months
|
Total summed score on PROMIS Global Health-10 that range from 4-20.Higher scores indicate greater health-related quality of life.
|
Baseline - 6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Carolyn Still, PhD, Case Western Reserve University, School of Nursing
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R21NR020489-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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