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Completed

NCT Number: 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) (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.

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Key information

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Baseline - 6 months

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

    Defined as the Number (%) of participants who achieved Systolic Blood Pressure < 130mmHg at Baseline and 6 months.

  2. Diastolic Blood Pressure

    Time frame: Baseline - 6 months

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

  3. PROMIS Global Health-10 [Health-related Quality of Life]

    Time frame: Baseline - 6 months

    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.

Sponsors and collaborators

Lead sponsor

Case Western Reserve University

Other

Collaborators

  • University Hospitals Cleveland Medical Center

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2022
Registry last updated
May 15, 2026

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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