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Trial record 1 of 15 for:    Resilience | Hypertension
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Self-Management and Resilience Trajectories in African American Adults With Hypertension

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ClinicalTrials.gov Identifier: NCT05308914
Recruitment Status : Recruiting
First Posted : April 4, 2022
Last Update Posted : October 5, 2022
Sponsor:
Collaborator:
University Hospitals Cleveland Medical Center
Information provided by (Responsible Party):
Carolyn Still, Case Western Reserve University

Study Description
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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
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
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Study Type : Observational
Estimated 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 : March 1, 2022
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : November 30, 2023

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. systolic and diastolic Blood Pressure [ Time Frame: 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] [ 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.


Biospecimen Retention:   None Retained

Specimens: Blood will be obtained at baseline, 3 months, and 6 months. Subjects will have blood samples (2 tubes, 1 teaspoon=5 ml each tube) drawn for Interleukin 6 (IIL-6) and High sensitivity C-reactive Protein (CRP) and cortisol serum to assess (~10 minutes to complete).

Hair samples will be obtain at baseline and 6 months for Cortisol Concentration


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05308914


Contacts
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Contact: Carolyn H Still, PhD 216-368-6338 carolyn.still@case.edu

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Carolyn H Still, PhD    216-844-3798    carolyn.still@uhhospitals.org   
Sponsors and Collaborators
Case Western Reserve University
University Hospitals Cleveland Medical Center
Investigators
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Principal Investigator: Carolyn Still, PhD Case Western Reserve University, School of Nursing
More Information
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Responsible Party: Carolyn Still, Assistant Professor, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT05308914    
Other Study ID Numbers: 1R21NR020489-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2022    Key Record Dates
Last Update Posted: October 5, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolyn Still, Case Western Reserve University:
Hypertension
Self-Management
Resilience
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases