Trial Outcomes & Findings for SMS System for Patients With Uncontrolled Hypertension (NCT NCT03596242)
NCT ID: NCT03596242
Last Updated: 2023-09-28
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
during screening period, about 6 months
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
High Blood Pressure Monitoring by Short Message Service (SMS)
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
High Blood Pressure Monitoring by Short Message Service (SMS)
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
SMS System for Patients With Uncontrolled Hypertension
Baseline characteristics by cohort
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
55.7 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 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)
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
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: during screening period, about 6 monthsOutcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Participants Screened
|
12 participants
|
12 participants
|
PRIMARY outcome
Timeframe: during baseline period, about 4 monthsOutcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Subjects Enrolled
|
12 participants
|
12 participants
|
PRIMARY outcome
Timeframe: baselinenumber of participants who refuse to participate at the time of recruitment and the reason why
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Subjects Who Refuse Participation
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baselineNumber of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Subjects Excluded Without SMS Capability
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksthe proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=12 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Proportion of Participants Continuing myHealth
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: This was only measured in the "High Blood Pressure Monitoring by SMS" arm.
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Participants Who Responded to SMS With At Least One Home BP Measurement
|
8 Participants
|
—
|
PRIMARY outcome
Timeframe: up to 12 weeksPopulation: This outcome was only measured in the "High Blood Pressure Monitoring by SMS" arm.
The number of patients who participate in SMS will be recorded
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=12 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
SMS Participation
|
12 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 12Population: Only 8 people in the SMS arm completed the questionnaire.
Participants will complete the SUS in person on an I-Pad or over the phone. The SUS yields a single score on a scale of 0-100. A SUS score above a 68 would be considered above average (better) usability.
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=8 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
System Usability Scale (SUS)
|
92.25 score on a scale
Standard Deviation 121.7
|
—
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Information not obtained for this outcome measure
The number of patients who demonstrate medication compliance via SMS will be recorded.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, week 12Score ranges from 0 to 10 with higher score denoting better medication adherence.
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=10 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=10 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Medication Adherence Questionnaire
baseline
|
2.17 score on a scale
Standard Deviation 0.93
|
2.02 score on a scale
Standard Deviation 0.7
|
|
Medication Adherence Questionnaire
Week 12
|
0.93 score on a scale
Standard Deviation 1.2
|
1.8 score on a scale
Standard Deviation 2.09
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Only 8/12 responded with their SBP in the "High Blood Pressure Monitoring by SMS" and 10/12 responded with their SBP in the "Usual Care Plus Standard Blood Pressure Monitoring".
Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=8 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=10 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Monitoring of SBP
|
15 mmHg
Standard Deviation 2.8
|
13 mmHg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: baseline and 12 weeksPopulation: Only 8/12 responded with their DBP in the "High Blood Pressure Monitoring by SMS" and only 10/12 responded with their DBP in the "Usual Care Plus Standard Blood Pressure Monitoring"
Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=8 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=10 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Monitoring of DBP
|
10 change in mmHg
Standard Deviation 3.2
|
8 change in mmHg
Standard Deviation 2.0
|
SECONDARY outcome
Timeframe: baseline/day 0 and 12 weeksNumber of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=10 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=10 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Initial and Follow up BP in Office
Baseline
|
10 Participants
|
10 Participants
|
|
Initial and Follow up BP in Office
Week 12
|
10 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: week 12No-show rate at 3 months' follow-up (f/u) clinic visits. If participants fail to come to their f/u visits within 7 days of their scheduled follow-up appointment, they will be considered as "no- shows".
Outcome measures
| Measure |
High Blood Pressure Monitoring by SMS
n=11 Participants
Will receive the text message intervention and will be provided with a blood pressure cuff in addition to standard blood pressure control education received at clinic visits
SMS System: Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
blood pressure control education: standard blood pressure control education given during visits
|
Usual Care Plus Standard Blood Pressure Monitoring
n=11 Participants
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
blood pressure control education: standard blood pressure control education given during visits
|
|---|---|---|
|
Number of Participants Considered No-Shows at Clinic Visits
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: up to 12 weeksPopulation: Measure data not collected
The time spent by the coordinator on study related patient activities will be recorded
Outcome measures
Outcome data not reported
Adverse Events
High Blood Pressure Monitoring by SMS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Plus Standard Blood Pressure Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Claudia L. Campos, MD
Wake Forest School of Medicine
Phone: [email protected]
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place