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

NCT04485637 | Completed Results

• 1 other identifier: BloodPressureCommunications
• Study Type: interventional
• Target: 542
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (4)

• 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

  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).

  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).

  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.

  Questionnaire completed immediately after receiving communication

Study Arms (3)

Communication with basic table

OTHER

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

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)

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

Other: Communication with enhanced graph

Interventions

Communication with basic table OTHER

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 basic table

Communication with enhanced table OTHER

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 table

Communication with enhanced graph OTHER

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

Communication with enhanced graph

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with hypertension
• Proficient in English

Sponsors & Collaborators

• University of Southern California: lead
• University of Pittsburgh: collaborator

Study Sites (1)

Pitt+Me Patient Registry

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Participants who agree to complete a survey on blood pressure communications are likely not representative of people with hypertension in the general population

Results Point of Contact

• Title: Wandi Bruine de Bruin
• Organization: University of Southern California

wandibdb@usc.edu

4126385875

Study Officials

• Wandi Bruine de Bruin, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Provost Professor

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 24, 2020
• Study Start: March 23, 2022
• Primary Completion: April 5, 2022
• Study Completion: April 5, 2022
• Last Updated: May 3, 2024
• Results First Posted: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)