Self-Management and Resilience Trajectories in African American Adults With Hypertension

NCT05308914 | Completed Results DMC

• 1 other identifier: 1R21NR020489-01A1
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension (HTN) rates have increased worldwide, but the most significant increase in the incidence of morbidity and mortality has been in African Americans (AA) (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.

Conditions

Hypertension; Self-Management; Quality of Life; Compliance, Medication; Compliance, Treatment; Compliance, Patient

Keywords

Hypertension; Self-Management; Resilience

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure

  Measure of participants' in clinic blood pressure (average of three blood pressure readings).

  Baseline - 6 months

• Diastolic Blood Pressure

  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]

  PROMIS Global Health-10 is divided into 2 separate components: Global Physical Health and Global Mental Health. The possible score ranges from 0 to 20 points in each component, where 0 points represent the patient's most severe state of physical and/or mental health, while 20 points represent the best possible state of physical and/or mental health. A higher score indicates better quality in domains of physical and/or mental health and functioning.

  Baseline - 6 months

Study Arms (1)

Resilience Study Cohort

Observational, descriptive longitudinal cohort design. See inclusion and exclusion criteria for more information

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants self-identify as African American, 25 years and older, who have a diagnosis of hypertension and living in the Greater Cleveland area.

You may qualify if:

• Self-identify as African American
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• University Hospitals Cleveland Medical Center: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Biospecimen

Retention: NONE RETAINED

Specimens: Blood will be obtained at baseline, 3 months, and 6 months. Subjects will have blood samples (2 tubes, 1 teaspoon=5 ml each tube) drawn for Interleukin 6 (IIL-6) and High sensitivity C-reactive Protein (CRP) and cortisol serum to assess (\~10 minutes to complete). Hair samples will be obtain at baseline and 6 months for Cortisol Concentration

MeSH Terms

Conditions

Hypertension; Medication Adherence; Patient Compliance

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Carolyn Still, Associate Professor & Assistant Dean of Research
• Organization: Case Western Reserve University

cwh11@case.edu

216-368-6338

Study Officials

• Carolyn Still, PhD

  Case Western Reserve University, School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: April 4, 2022
• Study Start: March 1, 2022
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-04

Locations

US (1)