Clinical trial NCT05308914: Self-Management and Resilience Trajectories in African American Adults With Hypertension
Official title: Self-Management and Resilience Trajectories in African American Adults With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Self-Management
Quality of Life
Compliance, Medication
Compliance, Treatment
Compliance, Patient
Keywords: Hypertension
Self-Management
Resilience
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2022-04-04
Enrollment: 125
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
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.

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)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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: systolic and diastolic Blood Pressure
timeFrame: Baseline - 6 months
measure: PROMIS Global Health-10 [health-related quality of life]
timeFrame: Baseline - 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Case Western Reserve University, School of Nursing
name: Carolyn Still, PhD
role: PRINCIPAL_INVESTIGATOR
References: