Trial Outcomes & Findings for A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement (NCT NCT03724487)
NCT ID: NCT03724487
Last Updated: 2022-08-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
baseline and 12 weeks
Results posted on
2022-08-16
Participant Flow
Participant milestones
| Measure |
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.
Coachman: 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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A COmmunity and Tech-Based ApproaCh for Hypertension Self-MANagement
Baseline characteristics by cohort
| Measure |
Coachman
n=30 Participants
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.
|
Enhanced Usual Care
n=30 Participants
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.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Continuous
|
58.97 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 9.49 • n=7 Participants
|
59.48 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Blood Pressure
Systolic Blood Pressure (in mmHg)
|
138.51 mm Hg
STANDARD_DEVIATION 14.77 • n=5 Participants
|
141.24 mm Hg
STANDARD_DEVIATION 16.92 • n=7 Participants
|
139.75 mm Hg
STANDARD_DEVIATION 15.67 • n=5 Participants
|
|
Blood Pressure
Diastolic Blood Pressure (in mmHg)
|
81.97 mm Hg
STANDARD_DEVIATION 13.45 • n=5 Participants
|
85.28 mm Hg
STANDARD_DEVIATION 12.61 • n=7 Participants
|
83.72 mm Hg
STANDARD_DEVIATION 12.84 • n=5 Participants
|
|
PROMIS Global Health
PROMIS Global Health-Mental Health Subscale
|
13.83 units on a scale
STANDARD_DEVIATION 2.83 • n=5 Participants
|
13.38 units on a scale
STANDARD_DEVIATION 2.46 • n=7 Participants
|
13.53 units on a scale
STANDARD_DEVIATION 2.62 • n=5 Participants
|
|
PROMIS Global Health
PROMIS Global Health-Physical Health Subscale
|
14.52 units on a scale
STANDARD_DEVIATION 2.85 • n=5 Participants
|
14.28 units on a scale
STANDARD_DEVIATION 2.68 • n=7 Participants
|
14.40 units on a scale
STANDARD_DEVIATION 2.79 • n=5 Participants
|
|
Education (in years)
|
14.52 years
STANDARD_DEVIATION 3.38 • n=5 Participants
|
14.70 years
STANDARD_DEVIATION 3.36 • n=7 Participants
|
14.6 years
STANDARD_DEVIATION 3.34 • n=5 Participants
|
|
Martial Status
Single
|
19 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Martial Status
Married
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Employment
Unemployed
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Employment
Employed
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Income
<$19,999
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Income
$20,000 - $59,999
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Income
>$60,000
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 12 weeksPopulation: Per protocol population, completing 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.
Outcome measures
| Measure |
Coachman
n=30 Participants
This group was exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.
|
Enhanced Usual Care (EUC)
n=30 Participants
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.
|
|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure
Systolic Blood Pressure Change from baseline at 12 weeks
|
0.55 mm Hg
Standard Deviation 1.84
|
-2.17 mm Hg
Standard Deviation 0.51
|
|
Change in Systolic and Diastolic Blood Pressure
Diastolic Blood Pressure Change from baseline at 12 weeks
|
-0.80 mm Hg
Standard Deviation 2.00
|
-1.04 mm Hg
Standard Deviation 0.55
|
PRIMARY outcome
Timeframe: Baseline and 12-weeksPopulation: Per protocol population, completing the baseline and 12-month visit
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).
Outcome measures
| Measure |
Coachman
n=30 Participants
This group was exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.
|
Enhanced Usual Care (EUC)
n=30 Participants
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.
|
|---|---|---|
|
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 0.30
|
0.34 score on a scale
Standard Deviation 0.93
|
|
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
|
-0.11 score on a scale
Standard Deviation 0.09
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Per protocol population, individuals in the Intervention Group
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%
Outcome measures
| Measure |
Coachman
n=30 Participants
This group was exposed to three Technology-based Interventions (TBI) accessible via smartphone and counseling from a local community nurse organization for hypertension self-management support.
|
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.
|
|---|---|---|
|
Achieved Blood Pressure Target of < 130/80 mm Hg at 12 Weeks
|
22 percentage of particioants
|
—
|
Adverse Events
Coachman
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Coachman
n=30 participants at risk
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.
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.
|
Enhanced Usual Care
n=30 participants at risk
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.
|
|---|---|---|
|
Vascular disorders
Hypertensive Crisis or urgency
|
0.00%
0/30 • 12 weeks
|
0.00%
0/30 • 12 weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Carolyn Still, Assistant Professr
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