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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05308914
• Other study ID #: 1R21NR020489-01A1
• Status: Active, not recruiting
• Start date: March 1, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: June 2024
• Source: Case Western Reserve University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Western Reserve University	University Hospitals Cleveland Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systolic and diastolic Blood Pressure	Measure of participants' in clinic blood pressure (average of three blood pressure readings).	Baseline - 6 months
Primary	PROMIS Global Health-10 [health-related quality of life]	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