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

• Sponsor: Case Western Reserve University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05308914
• Collaborator: University Hospitals Cleveland Medical Center (Other)
• Enrollment: 125
• Location: 1
• Anticipated Duration (Months): 21.9
• Patients Per Site Per Month: 5.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Self-Management; Quality of Life; Compliance, Medication; Compliance, Treatment; Compliance, Patient

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 125 participants
• Observational Model: Other
• Time Perspective: Other
• Official Title: Self-Management and Resilience Trajectories in African American Adults With Hypertension
• Actual Study Start Date: Jan 31, 2022
• Anticipated Primary Completion Date: Aug 31, 2023
• Anticipated Study Completion Date: Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Resilience Study Cohort Observational, descriptive longitudinal cohort design. See inclusion and exclusion criteria for more information

Outcome Measures

Primary Outcome Measures

1. systolic and diastolic Blood Pressure [Baseline - 6 months]

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical Center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• Case Western Reserve University
• University Hospitals Cleveland Medical Center

Investigators

• Principal Investigator: Carolyn Still, PhD, Case Western Reserve University, School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Carolyn Still, Assistant Professor, Case Western Reserve University
• ClinicalTrials.gov Identifier: NCT05308914
• Other Study ID Numbers: 1R21NR020489-01A1
• First Posted: Apr 4, 2022
• Last Update Posted: Apr 28, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Carolyn Still, Assistant Professor, Case Western Reserve University: Hypertension; Self-Management; Resilience
• Additional relevant MeSH terms: Hypertension

Study Results

No Results Posted as of Apr 28, 2022