Hypertension
Conditions
Keywords
high blood pressure, SMS, text messaging, monitoring
Brief summary
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.
Detailed description
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.
Interventions
OTHERSMS System
Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
BEHAVIORALblood pressure control education
standard blood pressure control education given during visits
Sponsors
National Center for Advancing Translational Sciences (NCATS)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have been diagnosed with hypertension * 18 and older * stage 2 hypertension or greater systolic blood pressure \[(SBP)\>140 and diastolic blood pressure (DBP) \>90\] who are receiving antihypertensive treatment.
Exclusion criteria
* Pregnancy * end-stage renal disease (on hemodialysis or peritoneal dialysis) * hospice or nursing home care * dementia * Patients who do not have a phone with Short Message Service (SMS) capabilities will also be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Scale (SUS) | Week 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. |
| Number of Participants Screened | during screening period, about 6 months | — |
| Number of Subjects Enrolled | during baseline period, about 4 months | — |
| Number of Subjects Who Refuse Participation | baseline | number of participants who refuse to participate at the time of recruitment and the reason why |
| Number of Subjects Excluded Without SMS Capability | baseline | Number of vulnerable subjects screened but excluded because they did not own a phone with SMS capability. |
| Proportion of Participants Continuing myHealth | up to 12 weeks | the proportion of participants who continue to use the myHealth tool per month through three months will be tracked for the intervention |
| Number of Participants Who Responded to SMS With At Least One Home BP Measurement | up to 12 weeks | — |
| SMS Participation | up to 12 weeks | The number of patients who participate in SMS will be recorded |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Questionnaire | baseline, week 12 | Score ranges from 0 to 10 with higher score denoting better medication adherence. |
| Monitoring of SBP | baseline and 12 weeks | Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded |
| Monitoring of DBP | baseline and 12 weeks | Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded |
| Initial and Follow up BP in Office | baseline/day 0 and 12 weeks | Number of participants to attended both initial and follow up blood pressure (systolic and diastolic) visits will be recorded. |
| Number of Participants Considered No-Shows at Clinic Visits | week 12 | 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. |
| Coordinator Time | up to 12 weeks | The time spent by the coordinator on study related patient activities will be recorded |
| Medication Adherence | up to 12 weeks | The number of patients who demonstrate medication compliance via SMS will be recorded. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Blood Pressure Monitoring by 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 | 12 |
| 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 | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 |
Baseline characteristics
| Characteristic | High Blood Pressure Monitoring by SMS | Total | Usual Care Plus Standard Blood Pressure Monitoring |
|---|---|---|---|
| Age, Continuous | 57.8 years STANDARD_DEVIATION 13 | 55.7 years STANDARD_DEVIATION 12 | 53.6 years STANDARD_DEVIATION 11.1 |
| 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 | 9 Participants | 19 Participants | 10 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 4 Participants | 2 Participants |
| Region of Enrollment United States | 12 participants | 24 participants | 12 participants |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 14 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 12 |
| other Total, other adverse events | 0 / 12 | 0 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 |
Outcome results
Primary
Number of Participants Screened
Time frame: during screening period, about 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Participants Screened | 12 participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Number of Participants Screened | 12 participants |
Primary
Number of Participants Who Responded to SMS With At Least One Home BP Measurement
Time frame: up to 12 weeks
Population: This was only measured in the High Blood Pressure Monitoring by SMS arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Participants Who Responded to SMS With At Least One Home BP Measurement | 8 Participants |
Primary
Number of Subjects Enrolled
Time frame: during baseline period, about 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Subjects Enrolled | 12 participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Number of Subjects Enrolled | 12 participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Subjects Excluded Without SMS Capability | 0 Participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Number of Subjects Excluded Without SMS Capability | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Subjects Who Refuse Participation | 0 Participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Number of Subjects Who Refuse Participation | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Proportion of Participants Continuing myHealth | 0 Participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Proportion of Participants Continuing myHealth | 0 Participants |
Primary
SMS Participation
The number of patients who participate in SMS will be recorded
Time frame: up to 12 weeks
Population: This outcome was only measured in the High Blood Pressure Monitoring by SMS arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | SMS Participation | 12 Participants |
Primary
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
Population: Only 8 people in the SMS arm completed the questionnaire.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Blood Pressure Monitoring by SMS | System Usability Scale (SUS) | 92.25 score on a scale | Standard Deviation 121.7 |
Secondary
Coordinator Time
The time spent by the coordinator on study related patient activities will be recorded
Time frame: up to 12 weeks
Population: Measure data not collected
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| High Blood Pressure Monitoring by SMS | Initial and Follow up BP in Office | Baseline | 10 Participants |
| High Blood Pressure Monitoring by SMS | Initial and Follow up BP in Office | Week 12 | 10 Participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Initial and Follow up BP in Office | Baseline | 10 Participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Initial and Follow up BP in Office | Week 12 | 10 Participants |
Secondary
Medication Adherence
The number of patients who demonstrate medication compliance via SMS will be recorded.
Time frame: up to 12 weeks
Population: Information not obtained for this outcome measure
Secondary
Medication Adherence Questionnaire
Score ranges from 0 to 10 with higher score denoting better medication adherence.
Time frame: baseline, week 12
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| High Blood Pressure Monitoring by SMS | Medication Adherence Questionnaire | baseline | 2.17 score on a scale | Standard Deviation 0.93 |
| High Blood Pressure Monitoring by SMS | Medication Adherence Questionnaire | Week 12 | 0.93 score on a scale | Standard Deviation 1.2 |
| Usual Care Plus Standard Blood Pressure Monitoring | Medication Adherence Questionnaire | baseline | 2.02 score on a scale | Standard Deviation 0.7 |
| Usual Care Plus Standard Blood Pressure Monitoring | Medication Adherence Questionnaire | Week 12 | 1.8 score on a scale | Standard Deviation 2.09 |
Secondary
Monitoring of DBP
Changes in values of Diastolic blood pressure (DBP) received via SMS will be recorded
Time frame: baseline and 12 weeks
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Blood Pressure Monitoring by SMS | Monitoring of DBP | 10 change in mmHg | Standard Deviation 3.2 |
| Usual Care Plus Standard Blood Pressure Monitoring | Monitoring of DBP | 8 change in mmHg | Standard Deviation 2 |
Secondary
Monitoring of SBP
Changes in values of Systolic blood pressure (SBP) received via SMS will be recorded
Time frame: baseline and 12 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Blood Pressure Monitoring by SMS | Monitoring of SBP | 15 mmHg | Standard Deviation 2.8 |
| Usual Care Plus Standard Blood Pressure Monitoring | Monitoring of SBP | 13 mmHg | Standard Deviation 3.4 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Blood Pressure Monitoring by SMS | Number of Participants Considered No-Shows at Clinic Visits | 1 participants |
| Usual Care Plus Standard Blood Pressure Monitoring | Number of Participants Considered No-Shows at Clinic Visits | 1 participants |