Trial Outcomes & Findings for Technology Coaching Intervention for Black Women With Hypertension (NCT NCT03577990)
NCT ID: NCT03577990
Last Updated: 2023-05-17
Results Overview
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Baseline to 3 months, 6 months, and 9 months.
Results posted on
2023-05-17
Participant Flow
Participants were recruited from areas frequented by Black women, including churches, sororities, clubs, community associations, neighborhood schools, and community events between January 2019 and April 2019. The first participant was enrolled on January 28, 2019, and the last participant was enrolled on April 13, 2019.
Of the 166 individuals approached for enrollment, 40 did not meet the inclusion criteria, 36 declined to participate, while 90 met the inclusion criteria and consented to participate in the study. The 90 participants were enrolled in the 6-week Chronic Disease Self-Management Program (CDSMP), and 83 completed the program and were randomized to treatment. Of the 83 participants, 77 had Fitbit data for analysis.
Participant milestones
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
Month 1-3
|
42
|
41
|
|
Overall Study
Month 4-6
|
41
|
39
|
|
Overall Study
Month 7-9
|
38
|
34
|
|
Overall Study
COMPLETED
|
37
|
32
|
|
Overall Study
NOT COMPLETED
|
8
|
13
|
Reasons for withdrawal
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
6
|
|
Overall Study
Withdrawal by Subject
|
4
|
7
|
Baseline Characteristics
Technology Coaching Intervention for Black Women With Hypertension
Baseline characteristics by cohort
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=42 Participants
Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale, along with coaching by means of personalized text messages.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=41 Participants
Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale.
Data were collected and compared at 3, 6, and 9 months.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
71 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 8.6 • n=93 Participants
|
52.7 years
STANDARD_DEVIATION 11.0 • n=4 Participants
|
54.1 years
STANDARD_DEVIATION 9.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
42 Participants
n=93 Participants
|
41 Participants
n=4 Participants
|
83 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=93 Participants
|
41 participants
n=4 Participants
|
83 participants
n=27 Participants
|
|
Years with Hypertension
|
11.0 years
STANDARD_DEVIATION 8.1 • n=93 Participants
|
9.8 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
10.4 years
STANDARD_DEVIATION 8.0 • n=27 Participants
|
|
Marital Status
Single (never married)
|
10 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Marital Status
Married
|
18 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Marital Status
Separated/Divorced
|
12 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
21 Participants
n=27 Participants
|
|
Marital Status
Widowed
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Education
Less than 12th grade
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Education
Completed high school
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Education
Some community college
|
7 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Education
Completed community college
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Education
Some 4-year college
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Education
Completed 4-year college
|
18 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
|
Education
Some graduate school
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Education
Completed graduate school
|
10 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Income
<10,000 - 24,999
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Income
25,000 - 54,999
|
14 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Income
55,000 - >100,000
|
21 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
44 Participants
n=27 Participants
|
|
Income
Refused
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Occupational Status
Work full-time
|
27 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
60 Participants
n=27 Participants
|
|
Occupational Status
Work part-time / Not employed
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Occupational Status
Retired with pension
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Baseline systolic blood pressure
|
140.1 mmHg
STANDARD_DEVIATION 11.0 • n=93 Participants
|
139.0 mmHg
STANDARD_DEVIATION 9.0 • n=4 Participants
|
139.6 mmHg
STANDARD_DEVIATION 10.0 • n=27 Participants
|
|
Baseline diastolic blood pressure
|
83.9 mmHg
STANDARD_DEVIATION 8.6 • n=93 Participants
|
84.3 mmHg
STANDARD_DEVIATION 7.0 • n=4 Participants
|
84.1 mmHg
STANDARD_DEVIATION 7.8 • n=27 Participants
|
|
Baseline weight
|
213.5 pounds
STANDARD_DEVIATION 47.2 • n=93 Participants
|
214.3 pounds
STANDARD_DEVIATION 52.2 • n=4 Participants
|
213.9 pounds
STANDARD_DEVIATION 49.7 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 months, 6 months, and 9 months.Population: Numbers may have decreased over time due to attrition and/or non-participation.
To show the change (decrease) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) over 9 months.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=42 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=41 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Baseline Systolic BP
|
140.07 mmHg
Standard Error 1.5781
|
139.03 mmHg
Standard Error 1.6841
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 3 Systolic BP
|
124.18 mmHg
Standard Error 1.9429
|
128.31 mmHg
Standard Error 1.9737
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 6 Systolic BP
|
125.80 mmHg
Standard Error 1.9606
|
126.13 mmHg
Standard Error 2.0827
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 9 Systolic BP
|
125.04 mmHg
Standard Error 1.7349
|
125.67 mmHg
Standard Error 1.8618
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Baseline Diastolic BP
|
83.8578 mmHg
Standard Error 1.2306
|
84.3161 mmHg
Standard Error 1.3132
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 3 Diastolic BP
|
82.8319 mmHg
Standard Error 1.4629
|
79.9767 mmHg
Standard Error 1.4749
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 6 Diastolic BP
|
83.2099 mmHg
Standard Error 1.3628
|
82.3126 mmHg
Standard Error 1.4482
|
|
Change in Systolic and Diastolic Blood Pressure (BP)
Month 9 Diastolic BP
|
82.5838 mmHg
Standard Error 1.4368
|
81.6017 mmHg
Standard Error 1.5639
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 6, and Month 9.Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
To show the proportion of days covered in the period of interest (Month 1, Month 3, Month 6, and Month 9). (Sum of days covered that participant reported medication adherence in the period of interest) ÷ (the number of days in the period of interest) x 100.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=41 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=36 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Medication Adherence by Proportion of Days Covered
Month 1 Med Adherence
|
0.7404 Proportion of days
Standard Error 0.06353
|
—
|
|
Medication Adherence by Proportion of Days Covered
Month 3 Med Adherence
|
0.6507 Proportion of days
Standard Error 0.06353
|
—
|
|
Medication Adherence by Proportion of Days Covered
Month 6 Med Adherence
|
0.5575 Proportion of days
Standard Error 0.06353
|
0.5357 Proportion of days
Standard Error 0.06779
|
|
Medication Adherence by Proportion of Days Covered
Month 9 Med Adherence
|
0.6507 Proportion of days
Standard Error 0.06353
|
0.5595 Proportion of days
Standard Error 0.06779
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 6, and Month 9.Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
To show the change (increase) in daily steps over 9 months.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=41 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=34 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Physical Activity (Change in Daily Steps)
Month 1 Steps
|
5778.58 steps
Standard Error 555.38
|
—
|
|
Physical Activity (Change in Daily Steps)
Month 3 Steps
|
5384.34 steps
Standard Error 593.17
|
—
|
|
Physical Activity (Change in Daily Steps)
Month 6 Steps
|
4720.90 steps
Standard Error 611.08
|
6413.73 steps
Standard Error 663.43
|
|
Physical Activity (Change in Daily Steps)
Month 9 Steps
|
4743.20 steps
Standard Error 770.29
|
5092.30 steps
Standard Error 798.81
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 6, and Month 9.Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
To show the change (decrease) in dietary intake (calories) over 9 months.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=41 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=30 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Change in Dietary Intake (Calories)
Month 1 Calories
|
1204.75 calories
Standard Error 81.7083
|
—
|
|
Change in Dietary Intake (Calories)
Month 3 Calories
|
1133.66 calories
Standard Error 92.0513
|
—
|
|
Change in Dietary Intake (Calories)
Month 6 Calories
|
801.42 calories
Standard Error 96.8770
|
803.38 calories
Standard Error 122.88
|
|
Change in Dietary Intake (Calories)
Month 9 Calories
|
1247.33 calories
Standard Error 146.01
|
1029.74 calories
Standard Error 165.78
|
SECONDARY outcome
Timeframe: Baseline to 3 months, 6 months, and 9 months.Population: Numbers may have decreased over time due to attrition and/or non-participation.
To show the change (decrease) in weight over 9 months.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=42 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=41 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Change in Weight
Baseline Weight
|
213.54 pounds
Standard Error 7.6390
|
214.31 pounds
Standard Error 8.1523
|
|
Change in Weight
Month 3 Weight
|
205.23 pounds
Standard Error 7.6767
|
212.20 pounds
Standard Error 8.1523
|
|
Change in Weight
Month 6 Weight
|
203.71 pounds
Standard Error 7.7075
|
203.71 pounds
Standard Error 8.2126
|
|
Change in Weight
Month 9 Weight
|
202.36 pounds
Standard Error 7.8919
|
205.40 pounds
Standard Error 8.4171
|
SECONDARY outcome
Timeframe: Month 1 to Month 3, Month 6, and Month 9.Population: In the IT arm, months 1-3, participants received usual care with no data collection and thus, there are no entries in these rows on the table. The information provided in the 'Other Statistical Analysis' field below clarifies that for the IT arm, months 1-6 in the statistical analysis corresponds to calendar months 4-9 of the data collection.
To show the change (decrease) in dietary intake (sodium) over 9 months.
Outcome measures
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=41 Participants
Fitbit Plus monitoring will include BP, weight measurements, daily food intake, self-report medication-taking, and physical activity plus weekly Interactive Technology-Enhanced Coaching (ITEC) for 3 months, then biweekly ITEC for 3 months, followed by another 3 months with no coaching to assess for sustainability.
Interactive Technology Enhanced Coaching (ITEC): As participants wear the activity tracker, take their BP and weight, along with input of food intake and medication-taking, data is transmitted in real time via Bluetooth Smart technology to the Fitbit Plus dashboard. All data is tracked, analyzed, and transparently displayed for participants to view and better understand their condition, and actively engage in self-care. Participants will be expected to use the information from the Fitbit dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care. In addition, staff will monitor data and communicate with participants to encourage active engagement in action plans by sending tailored coaching messages (ITEC) via the Fitbit Plus dashboard to the treatment arm weekly for 3 months, and biweekly for 3 months to motivate and support (BP control, medication adherence, and lifestyle modifications). After 6 months, the treatment arm will be monitored an additional 3 months with no tailored coaching for sustainability.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=30 Participants
Participants will receive usual care for 3 months followed by 6 months of only Fitbit Plus monitoring (with no ITEC) of BP, weight measurements, daily food intake, self-report medication-taking, and physical activity to be used for comparative data with the treatment arm.
Interactive Technology-No Coaching (IT): After receiving usual care for 3 months, the control arm will receive the same electronic monitoring as the treatment arm and data will be captured in the same manner with the Fitbit Plus dashboard. Participants will be expected to use the information from the dashboard and the Chronic Disease Self-Management Program (CDSMP) workshop as a guide to self-care without coaching (IT). Staff will only monitor data. Control participants will not be contacted between repeated measures data collection periods, except to send reminders if they are not participating daily.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Change in Dietary Intake (Sodium)
Month 1 Sodium
|
1363.65 mg
Standard Error 116.66
|
—
|
|
Change in Dietary Intake (Sodium)
Month 3 Sodium
|
1386.61 mg
Standard Error 134.26
|
—
|
|
Change in Dietary Intake (Sodium)
Month 6 Sodium
|
775.66 mg
Standard Error 141.33
|
928.30 mg
Standard Error 181.33
|
|
Change in Dietary Intake (Sodium)
Month 9 Sodium
|
1226.89 mg
Standard Error 179.26
|
1512.05 mg
Standard Error 241.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minutesQualitative questionnaire (included written responses to two open-ended questions) to gain insight and describe the psychological factor of stigma as an influence on poorly controlled hypertension in Black women. No scale was used to assess data.
Outcome measures
Outcome data not reported
Adverse Events
Interactive Technology Enhanced Coaching (ITEC)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Interactive Technology-No Coaching (IT)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Interactive Technology Enhanced Coaching (ITEC)
n=42 participants at risk
Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale, along with coaching by means of personalized text messages.
Data were collected and compared at 3, 6, and 9 months.
|
Interactive Technology-No Coaching (IT)
n=41 participants at risk
Chronic Disease Self-Management Program (CDSMP) and interactive technology using the smartphone for self-monitoring of 1) blood pressure with the Omron 10 wireless Bluetooth home BP monitor (Model BP786N), 2) medication adherence by checking each time medication was taken within the Fitbit Platform, 3) daily steps with the Fitbit Inspire HR activity tracker, 4) food intake (calories and sodium) with MyFitnessPal, and 5) weight with Fitbit Aria 2 weight scale.
Data were collected and compared at 3, 6, and 9 months.
|
|---|---|---|
|
Vascular disorders
Stroke
|
0.00%
0/42 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
2.4%
1/41 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Vascular disorders
Elevated diastolic blood pressure >110
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Musculoskeletal and connective tissue disorders
Dislodged patella
|
0.00%
0/42 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
2.4%
1/41 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Musculoskeletal and connective tissue disorders
Twisted ankle
|
0.00%
0/42 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
2.4%
1/41 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Surgical and medical procedures
Bunion surgery
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Surgical and medical procedures
Total knee replacement
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Surgical and medical procedures
Shoulder replacement
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Surgical and medical procedures
Glaucoma
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Gastrointestinal disorders
Abdominal pain and bleeding
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Gastrointestinal disorders
Stomach virus
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
2.4%
1/42 • Number of events 1 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
0.00%
0/41 • 42 weeks. Includes 6-week Chronic Disease Self-Management Program and 36 weeks of data collection.
Definitions do not differ.
|
Other adverse events
Adverse event data not reported
Additional Information
Willie M. Abel, Associate Professor of Nursing
The University of North Carolina at Charlotte
Phone: 704-687-7949
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place