Trial Outcomes & Findings for Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control (NCT NCT04485637)
NCT ID: NCT04485637
Last Updated: 2024-05-03
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
542 participants
Primary outcome timeframe
Questionnaire completed immediately after receiving communication
Results posted on
2024-05-03
Participant Flow
Participants were recruited through the Pitt+Me Patient Registry at the University of Pittsburgh
35 participants were eligible but did not participate in the study
Participant milestones
| Measure |
Communication With Basic Table
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
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 with enhanced table: 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 Graph
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
Communication with enhanced graph: 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
|
|---|---|---|---|
|
Overall Study
STARTED
|
188
|
176
|
178
|
|
Overall Study
COMPLETED
|
188
|
176
|
178
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Helping Hypertension Patients to Interpret Blood Pressure Readings and Motivate Blood Pressure Control
Baseline characteristics by cohort
| Measure |
Communication With Basic Table
n=188 Participants
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
n=176 Participants
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 with enhanced table: 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 Graph
n=178 Participants
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
Communication with enhanced graph: 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
|
Total
n=542 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
49.93 Years
STANDARD_DEVIATION .80 • n=5 Participants
|
50.73 Years
STANDARD_DEVIATION .89 • n=7 Participants
|
49.46 Years
STANDARD_DEVIATION .89 • n=5 Participants
|
50.03 Years
STANDARD_DEVIATION .50 • n=4 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
133 Participants
n=5 Participants
|
109 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
357 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
44 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
121 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
421 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
133 Participants
n=5 Participants
|
388 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
188 participants
n=5 Participants
|
176 participants
n=7 Participants
|
178 participants
n=5 Participants
|
542 participants
n=4 Participants
|
|
Diagnosed with hypertension or high blood pressure
|
188 Participants
n=5 Participants
|
176 Participants
n=7 Participants
|
178 Participants
n=5 Participants
|
542 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Questionnaire completed immediately after receiving communicationThis 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
Outcome measures
| Measure |
Communication With Basic Table
n=188 Participants
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
n=176 Participants
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 with enhanced table: 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 Graph
n=178 Participants
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
Communication with enhanced graph: 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
|
|---|---|---|---|
|
Number of Participants Who Measured Blood Pressure as Instructed (Assessed on Questionnaire)
|
34 Participants
|
47 Participants
|
50 Participants
|
PRIMARY outcome
Timeframe: Questionnaire completed immediately after receiving communicationThis 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).
Outcome measures
| Measure |
Communication With Basic Table
n=188 Participants
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
n=176 Participants
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 with enhanced table: 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 Graph
n=178 Participants
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
Communication with enhanced graph: 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
|
|---|---|---|---|
|
Number of Participants Who Understood Blood Pressure Readings (Assessed on Questionnaire)
|
166 Participants
|
161 Participants
|
155 Participants
|
PRIMARY outcome
Timeframe: Questionnaire completed immediately after receiving communicationOn 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).
Outcome measures
| Measure |
Communication With Basic Table
n=188 Participants
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
n=176 Participants
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 with enhanced table: 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 Graph
n=177 Participants
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
Communication with enhanced graph: 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
|
|---|---|---|---|
|
Evaluation of Blood Pressure Reading (Provided on Questionnaire)
|
3.04 Score on a scale (1-5)
Standard Deviation .90
|
2.98 Score on a scale (1-5)
Standard Deviation .94
|
2.90 Score on a scale (1-5)
Standard Deviation .89
|
PRIMARY outcome
Timeframe: Questionnaire completed immediately after receiving communicationOn 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.
Outcome measures
| Measure |
Communication With Basic Table
n=188 Participants
Blood pressure communication showing a basic table representing only the normal range of blood pressure readings
Communication with basic table: 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 Table
n=176 Participants
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 with enhanced table: 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 Graph
n=178 Participants
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
Communication with enhanced graph: 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
|
|---|---|---|---|
|
Behavioral Intention Index (Provided on Questionnaire)
|
3.58 Score on a scale (1-5)
Standard Deviation .83
|
3.45 Score on a scale (1-5)
Standard Deviation .96
|
3.54 Score on a scale (1-5)
Standard Deviation .85
|
Adverse Events
Communication With Basic Table
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Communication With Enhanced Table
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Communication With Enhanced Graph
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place