Text Messages and Blood Pressure Control
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2017 |
| Start Date: | September 2015 |
| End Date: | September 30, 2017 |
Hypertension Control Using Bi-directional Texting for Home Blood Pressure Monitoring
Hypertension remains one of the most important preventable contributors to disease and death.
It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is
associated with the greatest attributable risk for mortality among all modifiable risk
factors for cardiovascular events. Over 50 million people are living with hypertension in the
United States, and hypertension is one of the most common reasons for visits to a healthcare
provider. Abundant evidence from randomized controlled trials has shown benefit of
antihypertensive drug treatment in reducing important health outcomes in persons with
hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease.
Hypertension is more difficult to diagnose than other common medical illnesses. In most
cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they
do for other common symptomatic illness. Patients are frequently diagnosed after presenting
with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or
renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension
is that multiple blood pressure measurements are needed to establish a diagnosis. Blood
pressure readings can be falsely elevated in clinic due to the presence of an observer or the
clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure
reading is identified in a clinic setting, more readings are needed in order to make it
possible for physicians to decide about the next appropriate medical intervention. This need
for multiple BP measurements over time often delays both initiating and modifying medical
therapy for uncontrolled hypertension.
Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled
hypertension by reducing diagnostic uncertainty. In fact, home measurements are better
diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more
closely correlated with end-organ damage, and are cost effective and well-tolerated by
patients.
Patients are frequently asked to record their BP after clinic visits. Historically, patients
used a hand-written log, but more recently, patients are instructed to use an Internet-based
web portal that uploads values to the patient's electronic medical record. Compliance with
either approach relies on effective patient and provider followup, and in many settings,
nurses or pharmacists will need to call patients to prompt them for their blood pressure
measurements, which is both a costly and time consuming approach. Therefore, researchers need
to develop effective, yet low cost alternatives to monitoring home blood pressure.
This study proposes such a solution. The purpose of this study is to evaluate a simple
m-health intervention to increase the ease and efficacy of diagnosing uncontrolled
hypertension and achieve better blood pressure control in hypertensive patients.
It is the most common risk factor for strokes and myocardial infarctions in the U.S., and is
associated with the greatest attributable risk for mortality among all modifiable risk
factors for cardiovascular events. Over 50 million people are living with hypertension in the
United States, and hypertension is one of the most common reasons for visits to a healthcare
provider. Abundant evidence from randomized controlled trials has shown benefit of
antihypertensive drug treatment in reducing important health outcomes in persons with
hypertension. Yet, approximately 20% of U.S. adults are unaware that they have the disease.
Hypertension is more difficult to diagnose than other common medical illnesses. In most
cases, hypertension is asymptomatic; and accordingly patients do not seek care for it as they
do for other common symptomatic illness. Patients are frequently diagnosed after presenting
with end organ disease (e.g., myocardial infarctions, congestive heart failure, strokes, or
renal failure). Another complicating aspect related to diagnosing uncontrolled hypertension
is that multiple blood pressure measurements are needed to establish a diagnosis. Blood
pressure readings can be falsely elevated in clinic due to the presence of an observer or the
clinical surrounding (e.g., white coat hypertension). Even if an elevated blood pressure
reading is identified in a clinic setting, more readings are needed in order to make it
possible for physicians to decide about the next appropriate medical intervention. This need
for multiple BP measurements over time often delays both initiating and modifying medical
therapy for uncontrolled hypertension.
Having patients take their BP at home facilitates the more timely diagnosis of uncontrolled
hypertension by reducing diagnostic uncertainty. In fact, home measurements are better
diagnostic indicators of stroke and cardiovascular mortality than clinic readings, are more
closely correlated with end-organ damage, and are cost effective and well-tolerated by
patients.
Patients are frequently asked to record their BP after clinic visits. Historically, patients
used a hand-written log, but more recently, patients are instructed to use an Internet-based
web portal that uploads values to the patient's electronic medical record. Compliance with
either approach relies on effective patient and provider followup, and in many settings,
nurses or pharmacists will need to call patients to prompt them for their blood pressure
measurements, which is both a costly and time consuming approach. Therefore, researchers need
to develop effective, yet low cost alternatives to monitoring home blood pressure.
This study proposes such a solution. The purpose of this study is to evaluate a simple
m-health intervention to increase the ease and efficacy of diagnosing uncontrolled
hypertension and achieve better blood pressure control in hypertensive patients.
Half of the participants will be randomized to a "text-messaging" protocol, and the other
half will be randomized to a "standard of care" protocol.
Text messaging protocol: A trained research personnel (student, pharmacist, physician or
research assistant) will record the patient's cell phone number. Participants will select 7
morning and 7 evening times that are convenient for them to check and send blood pressure
measurements. (The literature recommends that 12-14 measurements should be taken over one to
weeks with morning and evening readings before making a diagnosis of hypertension).
Participants will use a home blood pressure monitor that will be provided to them after given
instruction of how to use it. This visit should take around 30 minutes.
After the participant leaves the clinic, at the pre-specified times and dates, an automated
server side script running on the investigators' server will check the application database
at a given time interval and at the appropriate times send the participant a text message
with specific, simple instructions. An example of the message is as follows: "Please remember
to check your blood pressure this morning at 7am! Reply to this message with your blood
pressure and time it was taken." The participant will return a short text with his/her blood
pressure measurements and the time they were taken: "150/90 and 145/88 7am". The
investigators' software will identify the cell phone number associated with each message and
will enter the blood pressure measurement, the time the blood pressure was recorded, and the
time the message was received into an account associated with that participant in our secure
database. If the participant does not complete the blood pressure homework assignment, a
pre-specified number of reminders will be sent to the patient until 2 weeks have elapsed.
Once the pre-specified number of measurements (seven days' worth of measurements) has been
received by the website, an email alert will be sent to the study personnel and a generated
document with blood pressure numbers will be sent to the treating physician e.g. physician's
clinical mailbox.
Standard of care protocol: participants who are randomized to the "Standard of Care" group
will be instructed to obtain 7 morning and 7 evening blood pressure measurements.
Participants will be asked to choose a method of communication to reply their blood pressure
numbers back to their physician. These include "MyChart" which is Internet-based web-portal
connected to the participant's electronic medical record, calling back the clinic with their
numbers, mailing, or faxing blood pressure log to their physician. The type of method each
participant chooses will be recorded. Participants will use a home blood pressure monitor
that will be provided to them after given instruction on how to use it.
Participants in both groups will be asked to return the blood pressure cuff to Iowa River
Landing Internal Medicine clinic. This can be done at any time that is convenient to them
after finishing the blood pressure assignment.
During the study, investigators will access the participants' medical record to obtain the
following information: latest blood pressure measurement, blood pressure medications, latest
cholesterol measurements, cholesterol medications, latest glucose measurement, other chronic
medical conditions, other medications, insurance, race, age, gender, marital status, height
and weight.
Medical records will also be accessed 3-6 months later to identify any change in medical
management that occurred after sending blood pressure readings. Time and type of intervention
will be recorded whether it is adding a new medication or increasing a current medication
dose. Also blood pressure readings during the next clinic visit (3-6 months after the study)
will be recorded.
half will be randomized to a "standard of care" protocol.
Text messaging protocol: A trained research personnel (student, pharmacist, physician or
research assistant) will record the patient's cell phone number. Participants will select 7
morning and 7 evening times that are convenient for them to check and send blood pressure
measurements. (The literature recommends that 12-14 measurements should be taken over one to
weeks with morning and evening readings before making a diagnosis of hypertension).
Participants will use a home blood pressure monitor that will be provided to them after given
instruction of how to use it. This visit should take around 30 minutes.
After the participant leaves the clinic, at the pre-specified times and dates, an automated
server side script running on the investigators' server will check the application database
at a given time interval and at the appropriate times send the participant a text message
with specific, simple instructions. An example of the message is as follows: "Please remember
to check your blood pressure this morning at 7am! Reply to this message with your blood
pressure and time it was taken." The participant will return a short text with his/her blood
pressure measurements and the time they were taken: "150/90 and 145/88 7am". The
investigators' software will identify the cell phone number associated with each message and
will enter the blood pressure measurement, the time the blood pressure was recorded, and the
time the message was received into an account associated with that participant in our secure
database. If the participant does not complete the blood pressure homework assignment, a
pre-specified number of reminders will be sent to the patient until 2 weeks have elapsed.
Once the pre-specified number of measurements (seven days' worth of measurements) has been
received by the website, an email alert will be sent to the study personnel and a generated
document with blood pressure numbers will be sent to the treating physician e.g. physician's
clinical mailbox.
Standard of care protocol: participants who are randomized to the "Standard of Care" group
will be instructed to obtain 7 morning and 7 evening blood pressure measurements.
Participants will be asked to choose a method of communication to reply their blood pressure
numbers back to their physician. These include "MyChart" which is Internet-based web-portal
connected to the participant's electronic medical record, calling back the clinic with their
numbers, mailing, or faxing blood pressure log to their physician. The type of method each
participant chooses will be recorded. Participants will use a home blood pressure monitor
that will be provided to them after given instruction on how to use it.
Participants in both groups will be asked to return the blood pressure cuff to Iowa River
Landing Internal Medicine clinic. This can be done at any time that is convenient to them
after finishing the blood pressure assignment.
During the study, investigators will access the participants' medical record to obtain the
following information: latest blood pressure measurement, blood pressure medications, latest
cholesterol measurements, cholesterol medications, latest glucose measurement, other chronic
medical conditions, other medications, insurance, race, age, gender, marital status, height
and weight.
Medical records will also be accessed 3-6 months later to identify any change in medical
management that occurred after sending blood pressure readings. Time and type of intervention
will be recorded whether it is adding a new medication or increasing a current medication
dose. Also blood pressure readings during the next clinic visit (3-6 months after the study)
will be recorded.
Inclusion Criteria:
- Any patient with at least one high blood pressure during any clinic visit over the
past 6 months who owns cell phone with texting capability.
- Eligible participants will be asked the following screening questions:
- "Do you have a cell phone with text messaging ability?", and "are you willing to
send your blood pressure numbers through text messages?". The participant should
answer "yes" to both questions to be eligible for the study.
Exclusion Criteria:
- Active or acute mental health problem;
- Significant cognitive impairment;
- Lack of fluency in speaking or understanding English;
- Pregnancy.
- Also, If the participant answers "NO" to any one of the screening two questions, they
will be excluded from the study.
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