HypertensionNCT05308914
Self-Management and Resilience Trajectories in African American Adults With Hypertension
An observational study of Hypertension and Self-Management, run by Case Western Reserve University at 1 site in United States.
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) (43% vs 27% for other U.S. population groups). Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Hypertension, Self-Management, Quality of Life
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 21 Mar 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
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.
Read the 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:
- 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.
- Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Identify resilience trajectory patterns and factors that influence HTN self-management behaviors over time.
- Conditions
- Hypertension, Self-Management, Quality of Life, Compliance, Medication, Compliance, Treatment, Compliance, Patient
- Keywords
- Hypertension, Self-Management, Resilience
- Medical subject headings
- Hypertension, Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Resilience Study Cohort | Observational, descriptive longitudinal cohort design. See inclusion and exclusion criteria for more information |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 6 months
Diastolic Blood Pressure
Measure of participants' in clinic blood pressure (average of three blood pressure readings).
Measured: 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.
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study start1 Mar 2022
- Primary completion21 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Principal investigator, Carolyn Still, Case Western Reserve University
- Investigators
- Carolyn Still, PhD, Principal investigator, Case Western Reserve University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05308914
- Sponsor's protocol ID
- 1R21NR020489-01A1
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2022
- Last updated
- 15 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Management and Resilience Trajectories in African American Adults With Hypertension
- ClinicalTrials.gov ID
- NCT05308914
- Acronym / sponsor ID
- 1R21NR020489-01A1
- Conditions
- Hypertension, Self-Management, Quality of Life, Compliance, Medication, Compliance, Treatment, Compliance, Patient
- Keywords
- Hypertension, Self-Management, Resilience
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 21 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 4 Apr 2022 (actual)
- Results
- Posted 28 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
- Determine if stress response mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Determine if self-management behaviors mediates the relationship between resilience precursors and health outcomes over time when controlling for risk regulators.
- Identify resilience trajectory patterns and factors that influence HTN self-management behaviors over time.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Resilience Study Cohort | – | –Observational, descriptive longitudinal cohort design. See inclusion and exclusion criteria for more information |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Systolic Blood Pressure
Time frame: Baseline - 6 months
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.
Diastolic Blood Pressure
Time frame: Baseline - 6 months
Measure of participants' in clinic blood pressure (average of three blood pressure readings).
PROMIS Global Health-10 [Health-related Quality of Life]
Time frame: Baseline - 6 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn Still, PhD principal investigator
Case Western Reserve University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Self-Management, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure (time frame: Baseline - 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.