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| Name | Class |
|---|---|
| University Hospitals Cleveland Medical Center | OTHER |
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Hypertension (HTN) rates have increased worldwide, but the most significant increase in the incidence of morbidity and mortality has been in African Americans (AA) (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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resilience Study Cohort | Observational, descriptive longitudinal cohort design. See inclusion and exclusion criteria for more information |
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| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Measure of participants' in clinic blood pressure (average of three blood pressure readings). Defined as the Number (%) of participants who achieved Systolic Blood Pressure < 130mmHg at Baseline and 6 months. | Baseline - 6 months |
| Diastolic Blood Pressure | 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] | PROMIS Global Health-10 is divided into 2 separate components: Global Physical Health and Global Mental Health. The possible score ranges from 0 to 20 points in each component, where 0 points represent the patient's most severe state of physical and/or mental health, while 20 points represent the best possible state of physical and/or mental health. A higher score indicates better quality in domains of physical and/or mental health and functioning. | Baseline - 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants self-identify as African American, 25 years and older, who have a diagnosis of hypertension and living in the Greater Cleveland area.
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn Still, PhD | Case Western Reserve University, School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
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Participants were recruited from clinics affiliated with University Hospitals Cleveland Medical Center (UHCMC), community centers, clinician referrals, and targeted advertisements from 2022 to 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | Resilience Study Cohort | Resilience Study Cohort is an observational, descriptive longitudinal cohort design, identifying distinct trajectories of resilience related to Hypertension self-management across three time points (baseline, Months 3 and 6) in African Americans (AA) with hypertension. Data were collected from valid and reliable surveys and biological mechanisms of resilience (serum samples). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 3 Months |
| |||||||||||||
| 6 Months |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Resilience Study Cohort | Resilience Study Cohort is an observational, descriptive longitudinal cohort design, identifying distinct trajectories of resilience related to Hypertension self-management across three time points (baseline, Months 3 and 6) in African Americans (AA) with hypertension. Data were collected from valid and reliable surveys and biological mechanisms of resilience (serum samples). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | One participant missed completing demographic survey. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Systolic Blood Pressure | Measure of participants' in clinic blood pressure (average of three blood pressure readings). Defined as the Number (%) of participants who achieved Systolic Blood Pressure < 130mmHg at Baseline and 6 months. | Some participants did not complete study measures/ blood pressure measures. | Posted | Mean | Standard Deviation | mmHg | Baseline - 6 months |
|
from baseline until the end of follow-up, up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Resilience Study Cohort | Resilience Study Cohort is an observational, descriptive longitudinal cohort design, identifying distinct trajectories of resilience related to Hypertension self-management across three time points (baseline, Months 3 and 6) in African Americans (AA) with hypertension. Data were collected from valid and reliable surveys and biological mechanisms of resilience (serum samples). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Very bad cold that lasted for 3 days. | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carolyn Still, Associate Professor & Assistant Dean of Research | Case Western Reserve University | 216-368-6338 | cwh11@case.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2023 | Feb 10, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
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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
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Race (NIH/OMB) | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Education Level | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Employment status | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Marital Status | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Insured | One participant missed completing demographic survey. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Diastolic Blood Pressure | Measure of participants' in clinic blood pressure (average of three blood pressure readings). | Some participants did not complete study measures/ blood pressure measures. | Posted | Mean | Standard Deviation | mmHg | Baseline - 6 months |
|
|
|
|
| Primary | PROMIS Global Health-10 [Health-related Quality of Life] | PROMIS Global Health-10 is divided into 2 separate components: Global Physical Health and Global Mental Health. The possible score ranges from 0 to 20 points in each component, where 0 points represent the patient's most severe state of physical and/or mental health, while 20 points represent the best possible state of physical and/or mental health. A higher score indicates better quality in domains of physical and/or mental health and functioning. | Some participants did not complete study measures/ PROMIS Global Health-10 [Health-related Quality of Life]. | Posted | Mean | Standard Deviation | Score on a scale | Baseline - 6 months |
|
|
|
|
| 0 |
| 125 |
| 0 |
| 125 |
| 13 |
| 125 |
| Episode of sciatic nerve pain | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Participant sent to the ER by her specialist after her BP numbers were high. | Cardiac disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Pt mentioned that she will have her port removed. | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| ER visit for muscle and nerve pain, non-cardiac related. | Musculoskeletal and connective tissue disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| ED Visit due to arterial puncture | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| ED visits due to gastrointestinal issues | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| ER visit due to extreme pancreatic pain | Gastrointestinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Had vascular testing for leg swelling. | Investigations | MedDRA 10.0 | Non-systematic Assessment |
|
| ED visit for wrist pain and headache. | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hospitalization for several extended periods of time due to several family members passing away. | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Hospital visit for pneumonia and RSV. | Respiratory, thoracic and mediastinal disorders | MedDRA 10.0 | Non-systematic Assessment |
|
| Involved in fender-bender resulted in an ED visit - not study-related. | Social circumstances | MedDRA 10.0 | Non-systematic Assessment |
|
| Prostate surgery and high scale on depression score | Surgical and medical procedures | MedDRA 10.0 | Non-systematic Assessment |
|
| ER visit for muscle and nerve pain | Nervous system disorders | MedDRA 10.0 | Non-systematic Assessment |
|
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| D015438 | Health Behavior |
| D001519 | Behavior |
|
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and Diastolic Blood Pressure (DBP), we conducted cross-sectional correlational analyses. | Spearman's correlation coefficient | 0.035 | Correlation between Diastolic Blood Pressure (DBP) and hypertension self-management behaviors (medication adherence to antihypertensives) | Coefficient correlation | 0.19 | Other | We used Spearman's rank correlation coefficient. |
|
| PROMIS Global Health-10: Physical Health subscale (Baseline) |
|
|
| PROMIS Global Health-10: Physical Health subscale (6 months) |
|
|
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes (Health-related Quality of Life: HQROL, Physical Subscale), we conducted cross-sectional correlational analyses. | Spearman's rank correlation | Correlation between health outcomes (HQROL:Physical Subscale) and hypertension selfmanagement behaviors (self-efficacy for chronic disease management) | 0.0000 | Coefficient correlation | 0.53 | Other | We used Spearman's rank correlation coefficient. |
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes (Health-related Quality of Life: HQROL), we conducted cross-sectional correlational analyses. | Spearman's rank correlation | Correlation between health outcomes (Health-related Quality of Life: HQROL, Mental Subscale) and resilience precursors (dispositional optimism) | 0.0000 | Coefficient correlation | 0.42 | Other | We used Spearman's rank correlation coefficient. |
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes (Health-related Quality of Life: HQROL), we conducted cross-sectional correlational analyses. | Spearman's rank correlation | Correlation between health outcomes (Health-related Quality of Life: HQROL, Mental Subscale) and resilience precursors (dispositional resilience) | 0.0000 | Coefficient correlation | 0.49 | Other | We used Spearman's rank correlation coefficient. |
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes (Health-related Quality of Life: HQROL), we conducted cross-sectional correlational analyses. | Spearman's rank correlation | Correlation between health outcomes (HQROL: Mental Subscale) and hypertension selfmanagement behaviors (self-efficacy for chronic disease management) | 0.0000 | Coefficient correlation | 0.44 | Other | We used Spearman's rank correlation coefficient. |
| To assess associations among resilience precursors, stress response, hypertension self-management behaviors, and health outcomes (Health-related Quality of Life: HQROL), we conducted cross-sectional correlational analyses. | Spearman's rank correlation | Correlation between health outcomes (Health-related Quality of Life: HQROL, Mental Subscale) and resilience precursors (Emotion Regulation) | 0.0003 | Coefficient correlation | 0.32 | Other | We used Spearman's rank correlation coefficient. |
| Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.050 | Coefficient of Indirect Effect Standard | 2.50 | 2-Sided | 95 | 0.001 | 5.01 | Other | Causal mediation analyses |
| Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.023 | Coefficient of Indirect Effect Standard | 2.50 | 2-Sided | 95 | 0.30 | 4.10 | Other | Causal mediation analyses |
| Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.006 | Coefficient of Indirect Effect Standard | 3.52 | 2-Sided | 95 | 0.99 | 6.04 | Other | Causal mediation analyses |
| Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.001 | Coefficient of Indirect Effect Standard | 5.38 | 2-Sided | 95 | 2.10 | 8.67 | Other | Causal mediation analyses |
| Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.026 | Coefficient of Indirect Effect Standard | 2.65 | 2-Sided | 95 | 0.31 | 4.99 | Other | Causal mediation analyses |
| Causal mediation analyses | 0.010 | Coefficient of Indirect Effect Standard | -3.22 | 2-Sided | 95 | -5.67 | -0.77 | Other | Causal mediation analyses |
| Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.018 | Coefficient of Indirect Effect Standard | 3.27 | 2-Sided | 95 | 0.56 | 5.99 | Other | Causal mediation analyses |
| Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators. | Causal mediation analyses | 0.046 | Coefficient of Indirect Effect Standard | -1.51 | 2-Sided | 95 | -2.99 | -0.02 | Other | Causal mediation analyses |