Community-based Participatory Research, Hypertension, Self-management, Technology
Conditions
Brief summary
The prevalence of hypertension among U.S. adults increased from 32% to 46% and African Americans are disproportionately impacted. Self-managing hypertension presents challenges such as dealing with complex treatment regimen, including critical components of recommended hypertension treatment such as self-blood pressure monitoring, and lifestyle modifications involving diet, exercise, and tobacco cessation. African Americans with hypertension have lower adherence to self-management behavior due to multifactorial reasons. Substantial evidence has demonstrated the important role of community support in improving patients' self-management of a variety of chronic illnesses, though integrating technology in such programs are rarely offered. The purpose of this study is to investigate the effectiveness of a community outreach program using a technology-based intervention (TBI) to support self-managing hypertension (called COACHMAN) to improve BP control.
Detailed description
COACHMAN targets barriers to hypertension knowledge, medication adherence, problem solving skills, patient-provider communication, and social support in an effort to improve blood pressure control. The investigators will conduct a two-arm randomized control trial (RCT) using a community participatory research approach and mixed methods to evaluate the efficacy of TBI intervention with community support (Coachman) compared to enhance usual care (ECU) among 60 African Americans with uncontrolled hypertension. The investigators aim to: 1. Identify key content, design, and resources from a community of stakeholders, including determining facilitators and barriers of hypertension self-management among African Americans that will inform the development of COACHMAN using a mixed methods approach methods. 2. Evaluate the feasibility and acceptability of COACHMAN to improve BP control. 3. Compare the difference in BP control between Technology-based intervention (TBI) and Enhanced usual care (EUC).
Interventions
BEHAVIORALCoachman
Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure.
BEHAVIORALEnhanced Usual Care (EUC)
Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.
Sponsors
University Hospitals Cleveland Medical Center
Case Western Reserve University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* self-identifying as African American * age 30 years or older * diagnosed with hypertension, with a blood pressure \>140/80 mmHg * prescribed at least one antihypertensive medication * able to read and understand English * own a smartphone
Exclusion criteria
* history of cognitive impairment * currently using a medication management app
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | baseline and 12 weeks | The primary outcome was a change (reduction) in both the systolic and diastolic blood pressure from baseline to 12 weeks, in which the 12 weeks mean systolic minus the baseline systolic were calculated. The same for 12 week diastolic BP minus the baseline diastolic BP were calculated for a mean change score. The change score (number) can range from no change (0) to a 10 point reduction in blood pressure. |
| Change in PROMIS Global Health-10 [Health-related Quality of Life] | Baseline and 12-weeks | Change in PROMIS Global Health-10 score (two subscales- Mental and Physical Health) from baseline to 12 weeks. Raw scores range from 4-20, higher scores represent better health. The change score is calculated as a mean difference between the two scores: at baseline and at 12 weeks. Scores are reported as a change value number, on a continuous number scale, that can be negative or positive (0 to 1, higher number better health). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks | 12 weeks | Achieved Blood Pressure target is defined as the rate of participants that have a blood pressure of at the end of 12 weeks, \< 130 mm Hg for systolic blood pressure and \<80 mmHg diastolic blood pressure, in the intervention group. Percentage of individuals that achieved blood pressure target can range from 0 -100% |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coachman The first study condition, A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (COACHMAN) will be exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support over 12 weeks.
TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure
Total of 30 individuals who:
1. self-identified as African American,
2. were 30 years of age or older,
3. had been diagnosed with hypertension (BP \>140/90 mmHg) and prescribed an antihypertensive drug,
4. were able to read/understand English, and (5) owned a smartphone. | 30 |
| Enhanced Usual Care The second study condition, Enhanced Usual Care (EUC) will be exposed to routine and standard hypertension education materials and one session on self-monitoring blood pressure.
Enhanced Usual Care (EUC): Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.
30 individuals who:
1. self-identified as African American,
2. were 30 years of age or older,
3. had been diagnosed with hypertension (BP \>140/90 mmHg) and prescribed an antihypertensive drug,
4. were able to read/understand English, and (5) owned a smartphone. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Enhanced Usual Care | Total | Coachman |
|---|---|---|---|
| Age, Continuous | 60.0 years STANDARD_DEVIATION 9.49 | 59.48 years STANDARD_DEVIATION 8.89 | 58.97 years STANDARD_DEVIATION 8.37 |
| Blood Pressure Diastolic Blood Pressure (in mmHg) | 85.28 mm Hg STANDARD_DEVIATION 12.61 | 83.72 mm Hg STANDARD_DEVIATION 12.84 | 81.97 mm Hg STANDARD_DEVIATION 13.45 |
| Blood Pressure Systolic Blood Pressure (in mmHg) | 141.24 mm Hg STANDARD_DEVIATION 16.92 | 139.75 mm Hg STANDARD_DEVIATION 15.67 | 138.51 mm Hg STANDARD_DEVIATION 14.77 |
| Education (in years) | 14.70 years STANDARD_DEVIATION 3.36 | 14.6 years STANDARD_DEVIATION 3.34 | 14.52 years STANDARD_DEVIATION 3.38 |
| Employment Employed | 16 Participants | 29 Participants | 13 Participants |
| Employment Unemployed | 14 Participants | 31 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 50 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 3 Participants |
| Income <$19,999 | 8 Participants | 16 Participants | 8 Participants |
| Income $20,000 - $59,999 | 11 Participants | 20 Participants | 9 Participants |
| Income >$60,000 | 11 Participants | 24 Participants | 13 Participants |
| Martial Status Married | 8 Participants | 19 Participants | 11 Participants |
| Martial Status Single | 22 Participants | 41 Participants | 19 Participants |
| PROMIS Global Health PROMIS Global Health-Mental Health Subscale | 13.38 units on a scale STANDARD_DEVIATION 2.46 | 13.53 units on a scale STANDARD_DEVIATION 2.62 | 13.83 units on a scale STANDARD_DEVIATION 2.83 |
| PROMIS Global Health PROMIS Global Health-Physical Health Subscale | 14.28 units on a scale STANDARD_DEVIATION 2.68 | 14.40 units on a scale STANDARD_DEVIATION 2.79 | 14.52 units on a scale STANDARD_DEVIATION 2.85 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 25 Participants | 45 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 15 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Change in PROMIS Global Health-10 [Health-related Quality of Life]
Change in PROMIS Global Health-10 score (two subscales- Mental and Physical Health) from baseline to 12 weeks. Raw scores range from 4-20, higher scores represent better health. The change score is calculated as a mean difference between the two scores: at baseline and at 12 weeks. Scores are reported as a change value number, on a continuous number scale, that can be negative or positive (0 to 1, higher number better health).
Time frame: Baseline and 12-weeks
Population: Per protocol population, completing the baseline and 12-month visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coachman | Change in PROMIS Global Health-10 [Health-related Quality of Life] | Chang in PROMIS Global Health-Metal Health Subscale | 0 score on a scale | Standard Deviation 0.3 |
| Coachman | Change in PROMIS Global Health-10 [Health-related Quality of Life] | Changes in PROMIS Global Health-Physical Health Subscale | -0.11 score on a scale | Standard Deviation 0.16 |
| Enhanced Usual Care (EUC) | Change in PROMIS Global Health-10 [Health-related Quality of Life] | Chang in PROMIS Global Health-Metal Health Subscale | 0.34 score on a scale | Standard Deviation 0.93 |
| Enhanced Usual Care (EUC) | Change in PROMIS Global Health-10 [Health-related Quality of Life] | Changes in PROMIS Global Health-Physical Health Subscale | -0.11 score on a scale | Standard Deviation 0.09 |
Primary
Change in Systolic and Diastolic Blood Pressure
The primary outcome was a change (reduction) in both the systolic and diastolic blood pressure from baseline to 12 weeks, in which the 12 weeks mean systolic minus the baseline systolic were calculated. The same for 12 week diastolic BP minus the baseline diastolic BP were calculated for a mean change score. The change score (number) can range from no change (0) to a 10 point reduction in blood pressure.
Time frame: baseline and 12 weeks
Population: Per protocol population, completing 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Coachman | Change in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure Change from baseline at 12 weeks | 0.55 mm Hg | Standard Deviation 1.84 |
| Coachman | Change in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure Change from baseline at 12 weeks | -0.80 mm Hg | Standard Deviation 2 |
| Enhanced Usual Care (EUC) | Change in Systolic and Diastolic Blood Pressure | Systolic Blood Pressure Change from baseline at 12 weeks | -2.17 mm Hg | Standard Deviation 0.51 |
| Enhanced Usual Care (EUC) | Change in Systolic and Diastolic Blood Pressure | Diastolic Blood Pressure Change from baseline at 12 weeks | -1.04 mm Hg | Standard Deviation 0.55 |
Secondary
Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks
Achieved Blood Pressure target is defined as the rate of participants that have a blood pressure of at the end of 12 weeks, \< 130 mm Hg for systolic blood pressure and \<80 mmHg diastolic blood pressure, in the intervention group. Percentage of individuals that achieved blood pressure target can range from 0 -100%
Time frame: 12 weeks
Population: Per protocol population, individuals in the Intervention Group
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Coachman | Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks | 22 percentage of particioants |