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Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Communication with basic table
Communication with enhanced table
Communication with enhanced graph
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with hypertension
  • Proficient in English

Exclusion Criteria:

-

Sites / Locations

  • Pitt+Me Patient RegistryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Communication with basic table

Communication with enhanced table

Communication with enhanced graph

Arm Description

Blood pressure communication showing a basic table representing only the normal range of blood pressure readings

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)

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

Outcomes

Primary Outcome Measures

Blood pressure measurement (reported on questionnaire)
Participants will be asked to measure their blood pressure twice, 1 minute apart, and record their diastolic and systolic blood pressure readings for each time on a questionnaire
Understanding of blood pressure reading (provided on questionnaire)
On a questionnaire, participants will be asked to indicate whether they think systolic and diastolic blood pressure readings are in the normal range (yes/no)
Evaluation of blood pressure reading (provided on questionnaire)
On a questionnaire, participants will be asked to indicate their perceptions of systolic and diastolic blood pressure readings on a scale from 1(=very bad) to 5 (=very good).
Behavioral intention index (provided on questionnaire)
On a questionnaire, participants will be asked 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, on a scale from 1 (=very unlikely) to 5 (=very likely)

Secondary Outcome Measures

Full Information

First Posted
July 20, 2020
Last Updated
March 28, 2022
Sponsor
University of Southern California
Collaborators
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT04485637
Brief Title
Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
Official Title
Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2022 (Actual)
Primary Completion Date
May 10, 2022 (Anticipated)
Study Completion Date
May 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. Patients with low health literacy have worse blood pressure control, perhaps because they 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. The American Heart Association has called for broad efforts to help empower hypertension patients from different backgrounds to control their blood pressure. Therefore, the investigators will evaluate different ways for helping hypertension patients to interpret their blood pressure readings and motivate blood pressure control, in a sample of hypertension patients varying in health literacy, age, and socio-economic status. Their strategy is based on insights from behavioral science studies, which suggest that people find it easier to interpret numbers when they can see the range of possible numbers. 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: : 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
650 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Communication with basic table
Arm Type
Other
Arm Description
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Arm Title
Communication with enhanced table
Arm Type
Other
Arm Description
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)
Arm Title
Communication with enhanced graph
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Communication with basic table
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Communication with enhanced table
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Communication with enhanced graph
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood pressure measurement (reported on questionnaire)
Description
Participants will be asked to measure their blood pressure twice, 1 minute apart, and record their diastolic and systolic blood pressure readings for each time on a questionnaire
Time Frame
Questionnaire completed immediately after receiving communication
Title
Understanding of blood pressure reading (provided on questionnaire)
Description
On a questionnaire, participants will be asked to indicate whether they think systolic and diastolic blood pressure readings are in the normal range (yes/no)
Time Frame
Questionnaire completed immediately after receiving communication
Title
Evaluation of blood pressure reading (provided on questionnaire)
Description
On a questionnaire, participants will be asked to indicate their perceptions of systolic and diastolic blood pressure readings on a scale from 1(=very bad) to 5 (=very good).
Time Frame
Questionnaire completed immediately after receiving communication
Title
Behavioral intention index (provided on questionnaire)
Description
On a questionnaire, participants will be asked 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, on a scale from 1 (=very unlikely) to 5 (=very likely)
Time Frame
Questionnaire completed immediately after receiving communication

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with hypertension Proficient in English Exclusion Criteria: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wandi Bruine de Bruin, PhD
Phone
412-638-5875
Email
wandibdb@usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wandi Bruine de Bruin, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pitt+Me Patient Registry
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wandi Bruine de Bruin
Phone
412-638-5875
First Name & Middle Initial & Last Name & Degree
Tamar Krishnamurti

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No personal identifiable patient information will be collected.

Learn more about this trial

Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control

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