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

February 26, 2024 updated by: Carolyn Still, Case Western Reserve University

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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

March 9, 2022

First Submitted That Met QC Criteria

March 24, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Estimated)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 26, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R21NR020489-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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