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临床试验/NCT05308914
NCT05308914已完成不适用

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

Case Western Reserve University2 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
2
主要终点
PROMIS Global Health-10 [health-related quality of life]

研究概览

简要总结

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.

详细描述

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:

  1. 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.
  2. Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
  3. Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
  4. Identify resilience trajectory patterns and factors that influence HTN self-management behaviors over time.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Resilience Study Cohort

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

结局指标

主要结局

PROMIS Global Health-10 [health-related quality of life]

时间窗: 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.

systolic and diastolic Blood Pressure

时间窗: Baseline - 6 months

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

Diastolic Blood Pressure

时间窗: Baseline - 6 months

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

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

时间窗: 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.

Systolic Blood Pressure

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carolyn Still

Assistant Professor

Case Western Reserve University

研究点 (2)

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