HypertensionNCT04485637
Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
A study testing Communication with basic table, Communication with enhanced table and Communication with enhanced graph in people with Hypertension, run by University of Southern California at 1 site in United States.
Trial summary
Hypertension is a major risk factor for cardiovascular disease, and a leading cause of death worldwide. Only about 50% of hypertension patients have good blood pressure control, perhaps because they find it hard to understand their blood pressure readings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Communication with basic table, Communication with enhanced table and Communication with enhanced graph
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 542 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 5 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosed with hypertension
- Proficient in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pitt+Me Patient Registry
Pittsburgh, Pennsylvania, 15213
About this study
Hypertension is a major risk factor for cardiovascular disease, and a leading cause of death worldwide. Only about 50% of hypertension patients have good blood pressure control, perhaps because they find it hard to understand their blood pressure readings. The investigators will evaluate ways to help hypertension patients to interpret their blood pressure readings and motivate blood pressure control.
Aim 1: Based on existing communications, the investigators will create 3 blood pressure communications:
Read more
(A) a basic table showing only the normal blood pressure range, which is often used in clinical practice and online communications about blood pressure, but may make it hard to interpret numbers outside of the normal range, potentially undermining behavior change intentions; (B) an enhanced table showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges, from the American Heart Association; (C) an enhanced graph to be adapted from Blood Pressure UK to show the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis.
Aim 2: : Among 650 diagnosed hypertension patients recruited through the University of Pittsburgh Medical Center (UPMC) Pitt+Me Patient Registry, the investigators will evaluate whether being presented with the enhanced table or graph (vs. basic table) affects patients' self-reported blood pressure measurement (as averaged across two measurements taken at the time of the survey at least 1 minute apart, as per directions of the American Heart Association), and improves interpretations of these two blood pressure readings and of hypothetical blood pressure readings, as well as behavior change intentions.
Aim 3: The investigators will examine whether Aim 2 findings vary by health literacy, age, and SES.
Read the detailed description
BACKGROUND Hypertension is a major modifiable risk factor for cardiovascular disease, and a leading cause of death worldwide. Lifetime risk of hypertension is 70-90%, but it is higher among adults who are older and of low socio-economic status (SES). Older age and lower SES are also associated with low health literacy, which undermines understanding of health information. Yet, low health literacy in hypertension patients is an independent predictor of poor blood pressure control, with only about 50% of hypertension patients having controlled blood pressure. Possibly, patients with lower health literacy find it harder to interpret whether blood pressure readings are high or low, reflect good or bad blood pressure control, and indicate a need for behavior change or medication use. Even college-educated hypertension patients who have bought home blood pressure monitors may struggle to interpret blood pressure readings that are outside the normal range, undermining their intentions to improve their blood pressure control.
BEHAVIORAL SCIENCE INSIGHT Lab studies in behavioral science have found that individuals' ability to interpret numbers (likely including blood pressure readings) is improved by showing the range or distribution - also called 'reference information'. In preliminary work, the PI showed that many people struggle to interpret credit card APRs, because they do not know what numbers are good or bad. In line with the behavioral science insight, the PI found that providing graphs with ranges of existing APRs helped recipients to see which credit cards posed a bad deal, and reduced their intentions to get such credit cards. It has been posited that providing reference information (e.g. normal and abnormal blood pressure ranges) should also help hypertension patients to interpret blood pressure readings, and help them to control their blood pressure.
If reference information is used when communicating blood pressure readings in clinics and online health records, it often involves a basic table that only shows the normal range (e.g., <120 for systolic and <80 for diastolic blood pressure). In one behavioral science study, 106 university staff performed similarly when using this basic table or when using a color-coded horizontal bar graph (showing the normal range in white and values outside the normal range in black). However, neither format followed the American Heart Association's communication, which shows more reference information for interpreting blood pressure readings outside of the normal range. Hypertension patients may need to see such enhanced reference information, because they are more likely to encounter blood pressure readings outside of the normal range. Moreover, those readings can be harder to interpret - perhaps especially for hypertension patients with low health literacy. The investigators propose to evaluate 2 formats for providing the more enhanced reference information from the American Heart Association, in either a table (as used by the American Heart Association), or a graph (as used by Blood Pressure UK, to be adapted to show the information from the American Heart Association). The behavioral science literature suggests that tables facilitate reading specific numbers, but that graphs help more with interpreting numbers as high or low, and good or bad - though that could depend on recipients' health literacy.
SPECIFIC AIMS The American Heart Association has called for broad-based efforts to improve the proportion of hypertension patients with controlled blood pressure, by "further engaging individuals in the hypertension control process" with "adequate representation of [specific] populations" including those with lower health literacy, older age, and lower SES. Therefore, the investigators propose to conduct an NIH Stage I primary data collection project, to evaluate the efficacy of interventions to facilitate blood pressure readings and motivate blood pressure control, in a sample of hypertension patients varying in health literacy, age, and SES.
Aim 1: Based on existing communications, the investigators' communication expertise (see below), and pilot tests with up to 10 hypertension patients, the investigators will generate 3 blood pressure communications:
(A) a basic table showing only the normal range, which is often used but may make it hard to interpret numbers outside of the normal range, potentially undermining behavior change intentions; (B) an enhanced table with more reference information, showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges, from the American Heart Association; (C) an enhanced graph to be adapted from Blood Pressure UK to show the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis.
Aim 2:: In a sample of 650 diagnosed hypertension patients recruited through the Pitt+Me Patient Registry at the University of Pittsburgh Medical Center (UPMC), the investigators will evaluate whether being presented with the enhanced table or graph (vs. basic table) affects patients' self-reported blood pressure measurement (as averaged across two measurements taken at the time of the survey at least 1 minute apart, as per directions of the American Heart Association), and improves interpretations of these two blood pressure readings and of hypothetical blood pressure readings, as well as behavior change intentions.
Aim 3: The investigators will examine whether Aim 2 findings vary by health literacy, age, and SES.
- Conditions
- Hypertension
- Being tested
- Communication with basic table, Communication with enhanced table, Communication with enhanced graph
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Communication with basic tableOther
Communication showing only the normal range of blood pressure readings, which is often used but may make it hard to interpret numbers outside of the normal range
Communication with enhanced tableOther
Communication with enhanced table, with reference information showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges (adapted from the American Heart Association)
Communication with enhanced graphOther
Communication with enhanced graph, showing reference information about how to interpret blood pressure readings (adapted from Blood Pressure UK) with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis
| Study group | Role | What they receive |
|---|---|---|
| Communication with basic table | Other | Blood pressure communication showing a basic table representing only the normal range of blood pressure readings Receives: Other: Communication with basic table |
| Communication with enhanced table | Other | Communication showing an enhanced table (Fig 1B) with more reference information for interpreting blood pressure readings, including how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges (adapted from the American Heart Association) Receives: Other: Communication with enhanced table |
| Communication with enhanced graph | Other | Communication showing an enhanced graph (adapted from Blood Pressure UK) for interpreting blood pressure readings, showing the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis Receives: Other: Communication with enhanced graph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Measured Blood Pressure as Instructed (Assessed on Questionnaire)
This outcome measure reflects the number of participants who measured their blood pressure as instructed, after seeing the communication (coded yes=1/no=0), as self-reported on the questionnaire
Measured: Questionnaire completed immediately after receiving communication
Number of Participants Who Understood Blood Pressure Readings (Assessed on Questionnaire)
This outcome measure reflects the number of patients who correctly answered two questions about blood pressure readings outside of the normal range, as included on the questionnaire (coded 1=both questions were answered correctly; 0=at least one of the questions was answered incorrectly). The first question asked whether or not blood pressure readings of 132/69 mmHg are considered normal (correct answer=no). The second question asked whether or not blood pressure readings of 142/91 are considered normal (correct answer=no).
Measured: Questionnaire completed immediately after receiving communication
Evaluation of Blood Pressure Reading (Provided on Questionnaire)
On a questionnaire, participants indicated their perceptions of how healthy they think their own blood pressure is right now, giving a score on a scale ranging from 1(=very unhealthy) to 5 (=very healthy).
Measured: Questionnaire completed immediately after receiving communication
Behavioral Intention Index (Provided on Questionnaire)
On a questionnaire, participants indicated how likely it is that they will try to lose weight, exercise more, take medication as recommended, and talk to their health care provider about improving their blood pressure readings, giving a score on a scale ranging from 1 (=very unlikely) to 5 (=very likely). This outcome measure reflects the average score across items.
Measured: Questionnaire completed immediately after receiving communication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start23 Mar 2022
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Wandi Bruine de Bruin, University of Southern California
- Investigators
- Wandi Bruine de Bruin, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485637
- Sponsor's protocol ID
- BloodPressureCommunications
- Status last verified
- May 2024
- First submitted
- 20 Jul 2020
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal identifiable patient information will be collected.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
- ClinicalTrials.gov ID
- NCT04485637
- Acronym / sponsor ID
- BloodPressureCommunications
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 24 Jul 2020 (actual)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypertension is a major risk factor for cardiovascular disease, and a leading cause of death worldwide. Only about 50% of hypertension patients have good blood pressure control, perhaps because they find it hard to understand their blood pressure readings. The investigators will evaluate ways to help hypertension patients to interpret their blood pressure readings and motivate blood pressure control.
Aim 1: Based on existing communications, the investigators will create 3 blood pressure communications:
(A) a basic table showing only the normal blood pressure range, which is often used in clinical practice and online communications about blood pressure, but may make it hard to interpret numbers outside of the normal range, potentially undermining behavior change intentions; (B) an enhanced table showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges, from the American Heart Association; (C) an enhanced graph to be adapted from Blood Pressure UK to show the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis.
Aim 2: : Among 650 diagnosed hypertension patients recruited through the University of Pittsburgh Medical Center (UPMC) Pitt+Me Patient Registry, the investigators will evaluate whether being presented with the enhanced table or graph (vs. basic table) affects patients' self-reported blood pressure measurement (as averaged across two measurements taken at the time of the survey at least 1 minute apart, as per directions of the American Heart Association), and improves interpretations of these two blood pressure readings and of hypothetical blood pressure readings, as well as behavior change intentions.
Aim 3: The investigators will examine whether Aim 2 findings vary by health literacy, age, and SES.
Detailed description
BACKGROUND Hypertension is a major modifiable risk factor for cardiovascular disease, and a leading cause of death worldwide. Lifetime risk of hypertension is 70-90%, but it is higher among adults who are older and of low socio-economic status (SES). Older age and lower SES are also associated with low health literacy, which undermines understanding of health information. Yet, low health literacy in hypertension patients is an independent predictor of poor blood pressure control, with only about 50% of hypertension patients having controlled blood pressure. Possibly, patients with lower health literacy find it harder to interpret whether blood pressure readings are high or low, reflect good or bad blood pressure control, and indicate a need for behavior change or medication use. Even college-educated hypertension patients who have bought home blood pressure monitors may struggle to interpret blood pressure readings that are outside the normal range, undermining their intentions to improve their blood pressure control.
BEHAVIORAL SCIENCE INSIGHT Lab studies in behavioral science have found that individuals' ability to interpret numbers (likely including blood pressure readings) is improved by showing the range or distribution - also called 'reference information'. In preliminary work, the PI showed that many people struggle to interpret credit card APRs, because they do not know what numbers are good or bad. In line with the behavioral science insight, the PI found that providing graphs with ranges of existing APRs helped recipients to see which credit cards posed a bad deal, and reduced their intentions to get such credit cards. It has been posited that providing reference information (e.g. normal and abnormal blood pressure ranges) should also help hypertension patients to interpret blood pressure readings, and help them to control their blood pressure.
If reference information is used when communicating blood pressure readings in clinics and online health records, it often involves a basic table that only shows the normal range (e.g., <120 for systolic and <80 for diastolic blood pressure). In one behavioral science study, 106 university staff performed similarly when using this basic table or when using a color-coded horizontal bar graph (showing the normal range in white and values outside the normal range in black). However, neither format followed the American Heart Association's communication, which shows more reference information for interpreting blood pressure readings outside of the normal range. Hypertension patients may need to see such enhanced reference information, because they are more likely to encounter blood pressure readings outside of the normal range. Moreover, those readings can be harder to interpret - perhaps especially for hypertension patients with low health literacy. The investigators propose to evaluate 2 formats for providing the more enhanced reference information from the American Heart Association, in either a table (as used by the American Heart Association), or a graph (as used by Blood Pressure UK, to be adapted to show the information from the American Heart Association). The behavioral science literature suggests that tables facilitate reading specific numbers, but that graphs help more with interpreting numbers as high or low, and good or bad - though that could depend on recipients' health literacy.
SPECIFIC AIMS The American Heart Association has called for broad-based efforts to improve the proportion of hypertension patients with controlled blood pressure, by "further engaging individuals in the hypertension control process" with "adequate representation of [specific] populations" including those with lower health literacy, older age, and lower SES. Therefore, the investigators propose to conduct an NIH Stage I primary data collection project, to evaluate the efficacy of interventions to facilitate blood pressure readings and motivate blood pressure control, in a sample of hypertension patients varying in health literacy, age, and SES.
Aim 1: Based on existing communications, the investigators' communication expertise (see below), and pilot tests with up to 10 hypertension patients, the investigators will generate 3 blood pressure communications:
(A) a basic table showing only the normal range, which is often used but may make it hard to interpret numbers outside of the normal range, potentially undermining behavior change intentions; (B) an enhanced table with more reference information, showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges, from the American Heart Association; (C) an enhanced graph to be adapted from Blood Pressure UK to show the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis.
Aim 2:: In a sample of 650 diagnosed hypertension patients recruited through the Pitt+Me Patient Registry at the University of Pittsburgh Medical Center (UPMC), the investigators will evaluate whether being presented with the enhanced table or graph (vs. basic table) affects patients' self-reported blood pressure measurement (as averaged across two measurements taken at the time of the survey at least 1 minute apart, as per directions of the American Heart Association), and improves interpretations of these two blood pressure readings and of hypothetical blood pressure readings, as well as behavior change intentions.
Aim 3: The investigators will examine whether Aim 2 findings vary by health literacy, age, and SES.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Communication with basic table | Other | Other: Communication with basic tableBlood pressure communication showing a basic table representing only the normal range of blood pressure readings |
| Communication with enhanced table | Other | Other: Communication with enhanced tableCommunication showing an enhanced table (Fig 1B) with more reference information for interpreting blood pressure readings, including how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges (adapted from the American Heart Association) |
| Communication with enhanced graph | Other | Other: Communication with enhanced graphCommunication showing an enhanced graph (adapted from Blood Pressure UK) for interpreting blood pressure readings, showing the same color-coded ranges as the enhanced table, with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with hypertension
- Proficient in English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Communication with basic tableCommunication showing only the normal range of blood pressure readings, which is often used but may make it hard to interpret numbers outside of the normal range | Other | Communication with basic table |
| Communication with enhanced tableCommunication with enhanced table, with reference information showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges (adapted from the American Heart Association) | Other | Communication with enhanced table |
| Communication with enhanced graphCommunication with enhanced graph, showing reference information about how to interpret blood pressure readings (adapted from Blood Pressure UK) with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis | Other | Communication with enhanced graph |
Primary outcome
Number of Participants Who Measured Blood Pressure as Instructed (Assessed on Questionnaire)
Time frame: Questionnaire completed immediately after receiving communication
This outcome measure reflects the number of participants who measured their blood pressure as instructed, after seeing the communication (coded yes=1/no=0), as self-reported on the questionnaire
Number of Participants Who Understood Blood Pressure Readings (Assessed on Questionnaire)
Time frame: Questionnaire completed immediately after receiving communication
This outcome measure reflects the number of patients who correctly answered two questions about blood pressure readings outside of the normal range, as included on the questionnaire (coded 1=both questions were answered correctly; 0=at least one of the questions was answered incorrectly). The first question asked whether or not blood pressure readings of 132/69 mmHg are considered normal (correct answer=no). The second question asked whether or not blood pressure readings of 142/91 are considered normal (correct answer=no).
Evaluation of Blood Pressure Reading (Provided on Questionnaire)
Time frame: Questionnaire completed immediately after receiving communication
On a questionnaire, participants indicated their perceptions of how healthy they think their own blood pressure is right now, giving a score on a scale ranging from 1(=very unhealthy) to 5 (=very healthy).
Behavioral Intention Index (Provided on Questionnaire)
Time frame: Questionnaire completed immediately after receiving communication
On a questionnaire, participants indicated how likely it is that they will try to lose weight, exercise more, take medication as recommended, and talk to their health care provider about improving their blood pressure readings, giving a score on a scale ranging from 1 (=very unlikely) to 5 (=very likely). This outcome measure reflects the average score across items.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No personal identifiable patient information will be collected.
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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.
Wandi Bruine de Bruin, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Communication with basic table, Communication with enhanced table and Communication with enhanced graph in people with Hypertension, run by University of Southern California 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 2 inclusion and 0 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 3 May 2024. 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?
Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Measured Blood Pressure as Instructed (Assessed on Questionnaire) (time frame: Questionnaire completed immediately after receiving communication). The study lists 4 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 3 May 2024.