HypertensionNCT02779231
Text Messages and Blood Pressure Control
A study testing Bi-directional texting in people with Hypertension, run by Linnea Polgreen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Bi-directional texting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 30 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Hypertension
- Being tested
- Bi-directional texting
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bi-directional textingOther
| Study group | Role | What they receive |
|---|---|---|
| Texting group | Experimental | This group will be enrolled in bi-directional texting to send back blood pressure. Receives: Other: Bi-directional texting |
| Standard of care group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' response to texting.
The number of participants who completed the home blood pressure assignment will be compared between the two groups. These data will be extracted from the medical records for the standard of care group and from the "texting" website for the texting group.
Measured: 15 days
Physicians' response to blood pressure information.
The number of physicians who reacted to the blood pressure readings with any kind of clinical intervention (life style discussion, medication modification, ets.) will be compared between the two groups. These data will be extracted from the medical records.
Measured: 30 days
Diagnosis rates between the text-messages and the standard of care groups.
Measured: 6 months
Secondary outcomes (2)
Time to intervention by physicians between the two groups
Measured: 30 days
Difference in blood pressure reduction between the two groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startSep 2015
- Primary completion30 Sep 2017
- Study completion30 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linnea Polgreen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Linnea Polgreen, University of Iowa
- Investigators
- Philip Polgreen, M.D. Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779231
- Sponsor's protocol ID
- 201509761
- Status last verified
- Nov 2017
- First submitted
- 16 May 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertension Control Using Bi-directional Texting for Home Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT02779231
- Acronym / sponsor ID
- 201509761
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Linnea PolgreenUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 30 Sep 2017 (actual)
- First posted
- 20 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Texting group | Experimental | Other: Bi-directional textingThis group will be enrolled in bi-directional texting to send back blood pressure. |
| Standard of care group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bi-directional texting | Other | Texting group |
Primary outcome
Patients' response to texting.
Time frame: 15 days
The number of participants who completed the home blood pressure assignment will be compared between the two groups. These data will be extracted from the medical records for the standard of care group and from the "texting" website for the texting group.
Physicians' response to blood pressure information.
Time frame: 30 days
The number of physicians who reacted to the blood pressure readings with any kind of clinical intervention (life style discussion, medication modification, ets.) will be compared between the two groups. These data will be extracted from the medical records.
Diagnosis rates between the text-messages and the standard of care groups.
Time frame: 6 months
2 secondary outcomes
Time to intervention by physicians between the two groups
Time frame: 30 days
Difference in blood pressure reduction between the two groups
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Polgreen, M.D. Ph.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-directional texting in people with Hypertension, run by Linnea Polgreen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients' response to texting. (time frame: 15 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.