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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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 groups in NCT04485637
Study groupRoleWhat they receive
Communication with basic tableOtherBlood pressure communication showing a basic table representing only the normal range of blood pressure readings
Receives: Other: Communication with basic table
Communication with enhanced tableOtherCommunication 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 graphOtherCommunication 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.

  1. 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

  2. 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

  3. 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

  4. 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.

  1. First posted24 Jul 2020
  2. Study start23 Mar 2022
  3. Primary completion5 Apr 2022
  4. Study completion5 Apr 2022

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No personal identifiable patient information will be collected.

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.

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