Trial Outcomes & Findings for Self-Management and Resilience Trajectories in African American Adults With Hypertension (NCT NCT05308914)
NCT ID: NCT05308914
Last Updated: 2026-05-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
125 participants
Primary outcome timeframe
Baseline - 6 months
Results posted on
2026-05-15
Participant Flow
Participants were recruited from clinics affiliated with University Hospitals Cleveland Medical Center (UHCMC), community centers, clinician referrals, and targeted advertisements from 2022 to 2024.
Participant milestones
| Measure |
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).
|
|---|---|
|
Baseline
STARTED
|
125
|
|
Baseline
COMPLETED
|
125
|
|
Baseline
NOT COMPLETED
|
0
|
|
3 Months
STARTED
|
125
|
|
3 Months
COMPLETED
|
109
|
|
3 Months
NOT COMPLETED
|
16
|
|
6 Months
STARTED
|
109
|
|
6 Months
COMPLETED
|
98
|
|
6 Months
NOT COMPLETED
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One participant missed completing demographic survey.
Baseline characteristics by cohort
| Measure |
Resilience Study Cohort
n=125 Participants
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).
|
|---|---|
|
Age, Customized
Age
|
62.66 Years
STANDARD_DEVIATION 12.32 • n=124 Participants • One participant missed completing demographic survey.
|
|
Sex: Female, Male
Female
|
83 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Sex: Female, Male
Male
|
41 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
Black or African American
|
124 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
White
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Education Level
Less than high school
|
9 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Education Level
Graduated from high school
|
21 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Education Level
Greater than high school/Trade School
|
51 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Education Level
College degree
|
43 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Employment status
Employed
|
60 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Employment status
Not employed
|
57 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Employment status
No reports on employment status
|
7 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Marital Status
Single
|
85 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Marital Status
Married
|
38 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Marital Status
No reports on marital status
|
1 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Insured
Medicaid
|
25 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Insured
Medicare
|
29 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Insured
Veteran Benefits
|
4 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Insured
Private
|
43 Participants
n=124 Participants • One participant missed completing demographic survey.
|
|
Insured
More than one insurance
|
23 Participants
n=124 Participants • One participant missed completing demographic survey.
|
PRIMARY outcome
Timeframe: Baseline - 6 monthsPopulation: Some participants did not complete study measures/ blood pressure measures.
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.
Outcome measures
| Measure |
Resilience Study Cohort
n=125 Participants
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).
|
|---|---|
|
Systolic Blood Pressure
Systolic Blood Pressure (Baseline)
|
138.35 mmHg
Standard Deviation 15.18
|
|
Systolic Blood Pressure
Systolic Blood Pressure (6 months)
|
135.56 mmHg
Standard Deviation 18.93
|
PRIMARY outcome
Timeframe: Baseline - 6 monthsPopulation: Some participants did not complete study measures/ blood pressure measures.
Measure of participants' in clinic blood pressure (average of three blood pressure readings).
Outcome measures
| Measure |
Resilience Study Cohort
n=125 Participants
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).
|
|---|---|
|
Diastolic Blood Pressure
Diastolic Blood Pressure (6 months)
|
76.37 mmHg
Standard Deviation 10.92
|
|
Diastolic Blood Pressure
Diastolic Blood Pressure (Baseline)
|
79.97 mmHg
Standard Deviation 13.31
|
PRIMARY outcome
Timeframe: Baseline - 6 monthsPopulation: Some participants did not complete study measures/ 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.
Outcome measures
| Measure |
Resilience Study Cohort
n=125 Participants
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).
|
|---|---|
|
PROMIS Global Health-10 [Health-related Quality of Life]
PROMIS Global Health-10: Mental Health subscale (Baseline)
|
12.90 Score on a scale
Standard Deviation 2.92
|
|
PROMIS Global Health-10 [Health-related Quality of Life]
PROMIS Global Health-10: Mental Health subscale (6 months)
|
12.78 Score on a scale
Standard Deviation 2.93
|
|
PROMIS Global Health-10 [Health-related Quality of Life]
PROMIS Global Health-10: Physical Health subscale (Baseline)
|
13.61 Score on a scale
Standard Deviation 3.14
|
|
PROMIS Global Health-10 [Health-related Quality of Life]
PROMIS Global Health-10: Physical Health subscale (6 months)
|
13.49 Score on a scale
Standard Deviation 2.95
|
Adverse Events
Resilience Study Cohort
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Resilience Study Cohort
n=125 participants at risk
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).
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Very bad cold that lasted for 3 days.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Musculoskeletal and connective tissue disorders
Episode of sciatic nerve pain
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Cardiac disorders
Participant sent to the ER by her specialist after her BP numbers were high.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Surgical and medical procedures
Pt mentioned that she will have her port removed.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Musculoskeletal and connective tissue disorders
ER visit for muscle and nerve pain, non-cardiac related.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Investigations
ED Visit due to arterial puncture
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Gastrointestinal disorders
ED visits due to gastrointestinal issues
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Gastrointestinal disorders
ER visit due to extreme pancreatic pain
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Investigations
Had vascular testing for leg swelling.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Nervous system disorders
ED visit for wrist pain and headache.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Nervous system disorders
Hospitalization for several extended periods of time due to several family members passing away.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Hospital visit for pneumonia and RSV.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Social circumstances
Involved in fender-bender resulted in an ED visit - not study-related.
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Surgical and medical procedures
Prostate surgery and high scale on depression score
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
|
Nervous system disorders
ER visit for muscle and nerve pain
|
0.80%
1/125 • from baseline until the end of follow-up, up to 6 months
|
Additional Information
Dr. Carolyn Still, Associate Professor & Assistant Dean of Research
Case Western Reserve University
Phone: 216-368-6338
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place