An interventional study of SMS System and blood pressure control education in Hypertension, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-28.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Supportive care
This is a pilot study to determine the potential of utilizing Short Message Service (SMS) messaging to improve health outcomes for patients with uncontrolled hypertension receiving care from the Outpatient Internal Medicine Clinic at Wake Forest Baptist Hospital.
The pilot will evaluate the feasibility of implementing a Short Message Service (SMS) system and Home Blood Pressure Measurements (HBPM) in the Outpatient Internal Medicine (OPD) clinic at Wake Forest Baptist Hospital. Implementing a new short text messaging service will improve the health delivery system in three ways. 1) Increasing patient engagement: SMS and HBPM require an active commitment by the patients themselves in their medical care and results in a marked improvement in the adherence to medication. High adherence to home blood pressure (BP) measurements has also been reported to improve BP control. 2) Supporting patients outside of the office visits by identifying and resolving barriers to medication adherence earlier on (i.e. if patients are unable to get their prescriptions or are having significant side effects). 3) Adopting clinical guidelines to improve BP control in a vulnerable population.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 24 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Other: SMS System · Behavioral: blood pressure control education
Will receive standard blood pressure care and education, as well as a blood pressure cuff at their clinic visits
Behavioral: blood pressure control education
Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
standard blood pressure control education given during visits
Number of Participants Screened
Time frame: during screening period, about 6 months
Number of Subjects Enrolled
Time frame: during baseline period, about 4 months
Number of Subjects Who Refuse Participation
number of participants who refuse to participate at the time of recruitment and the reason why
Time frame: baseline
Number of Subjects Excluded Without SMS Capability
Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
Time frame: baseline
Proportion of Participants Continuing myHealth
the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention
Time frame: up to 12 weeks
Number of Participants Who Responded to SMS With At Least One Home BP Measurement
Time frame: up to 12 weeks
SMS Participation
The number of patients who participate in SMS will be recorded
Time frame: up to 12 weeks
System Usability Scale (SUS)
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.
Time frame: Week 12
Medication Adherence
The number of patients who demonstrate medication compliance via SMS will be recorded.
Time frame: up to 12 weeks
Medication Adherence Questionnaire
Score ranges from 0 to 10 with higher score denoting better medication adherence.
Time frame: baseline, week 12
Monitoring of SBP
Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
Time frame: baseline and 12 weeks
Monitoring of DBP
Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
Time frame: baseline and 12 weeks
Initial and Follow up BP in Office
Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.
Time frame: baseline/day 0 and 12 weeks
Number of Participants Considered No-Shows at Clinic Visits
No-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".
Time frame: week 12
Coordinator Time
The time spent by the coordinator on study related patient activities will be recorded
Time frame: up to 12 weeks
| Milestone | High Blood Pressure Monitoring by Short Message Service (SMS) | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Started | 12 | 12 |
| Completed | 10 | 10 |
| Not completed | 2 | 2 |
| Withdrew: Lost to follow-up | 2 | 2 |
| participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Number of Participants Screened | 12 | 12 |
| participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Number of Subjects Enrolled | 12 | 12 |
number of participants who refuse to participate at the time of recruitment and the reason why
| Participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Number of Subjects Who Refuse Participation | 0 | 0 |
Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability.
| Participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Number of Subjects Excluded Without SMS Capability | 0 | 0 |
the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention
| Participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Proportion of Participants Continuing myHealth | 0 | 0 |
| Participants | High Blood Pressure Monitoring by SMS |
|---|---|
| Number of Participants Who Responded to SMS With At Least One Home BP Measurement | 8 |
The number of patients who participate in SMS will be recorded
| Participants | High Blood Pressure Monitoring by SMS |
|---|---|
| SMS Participation | 12 |
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.
| score on a scale | High Blood Pressure Monitoring by SMS |
|---|---|
| System Usability Scale (SUS) | 92.25 ± 121.7 |
The number of patients who demonstrate medication compliance via SMS will be recorded.
No measurements were reported for this outcome.
Score ranges from 0 to 10 with higher score denoting better medication adherence.
| score on a scale | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| baseline | 2.17 ± 0.93 | 2.02 ± 0.7 |
| Week 12 | 0.93 ± 1.2 | 1.8 ± 2.09 |
Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
| mmHg | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Monitoring of SBP | 15 ± 2.8 | 13 ± 3.4 |
Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
| change in mmHg | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Monitoring of DBP | 10 ± 3.2 | 8 ± 2.0 |
Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded.
| Participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Baseline | 10 | 10 |
| Week 12 | 10 | 10 |
No-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".
| participants | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|
| Number of Participants Considered No-Shows at Clinic Visits | 1 | 1 |
The time spent by the coordinator on study related patient activities will be recorded
No measurements were reported for this outcome.
Collected over baseline through week 12. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Blood Pressure Monitoring by SMS | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Usual Care Plus Standard Blood Pressure Monitoring | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Age, Continuous(years) | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring | Total |
|---|---|---|---|
| Mean | 57.8 ± 13.0 | 53.6 ± 11.1 | 55.7 ± 12.0 |
| Sex: Female, Male(Participants) | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring | Total |
|---|---|---|---|
| Female | 4 | 6 | 10 |
| Male | 8 | 6 | 14 |
| Race (NIH/OMB)(Participants) | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 10 | 19 |
| White | 2 | 2 | 4 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | High Blood Pressure Monitoring by SMS | Usual Care Plus Standard Blood Pressure Monitoring | Total |
|---|---|---|---|
| United States | 12 | 12 | 24 |
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Wake Forest University Health Sciences