Trial Outcomes & Findings for Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool (NCT NCT03974334)

Last Updated: 2021-02-24

Results Overview

The Blood Pressure Knowledge Questionnaire (BPKQ) was used to assess the participants' level of knowledge regarding common characteristics and risk factors of hypertension. It consists of 8 items covering topics like common symptoms, White Coat Syndrome, and the amount of salt consumed by the average American, with a mix of multiple choice (6 items) and true/false questions (2 items). The correct items are totaled, with a range of 1-8, and higher scores indicating more hypertension knowledge. The information needed to answer each item correctly was covered in OWL-H's curriculum.

Recruitment status

COMPLETED

Study phase

Target enrollment

25 participants

Primary outcome timeframe

8 Week

Results posted on

2021-02-24

Participant Flow

Participants were recruited from July-October of 2019 from Worcester, MA area adult primary care clinics, and either self-referred (via flyers and brochures placed around the clinics) or were referred by their primary care providers.They were then screened for eligibility, including a current diagnosis of hypertension in their EMR, and consented.

Participant milestones

Participant milestones
Measure	OWL-Hypertension 8 Wk Trial Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Overall Study STARTED	25
Overall Study COMPLETED	24
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	OWL-Hypertension 8 Wk Trial Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Overall Study Lost to Follow-up	1

Baseline Characteristics

One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	OWL-Hypertension 8 Wk Trial n=24 Participants Two groups of thirteen participants will use the Our Whole Lives - Hypertension eHealth online tool for 8 weeks each, with baseline, midline, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Age, Continuous	57 years STANDARD_DEVIATION 12.1 • n=24 Participants
Sex: Female, Male Female	21 Participants n=24 Participants
Sex: Female, Male Male	3 Participants n=24 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=24 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 Participants n=24 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=24 Participants
Race (NIH/OMB) Asian	1 Participants n=24 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	2 Participants n=24 Participants
Race (NIH/OMB) White	15 Participants n=24 Participants
Race (NIH/OMB) More than one race	3 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=24 Participants
Region of Enrollment United States	24 participants n=24 Participants
Blood Pressure Knowledge Questionnaire	5.58 Scores on a scale STANDARD_DEVIATION 1.44 • n=24 Participants
Hypertension Self-Care Profile Self-Efficacy Instrument	63.67 Scores on a scale STANDARD_DEVIATION 9.06 • n=24 Participants
Mediterranean Diet Questionnaire	7.65 Scores on a scale STANDARD_DEVIATION 2.19 • n=23 Participants • One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.
Blood Pressure Self-Monitoring (Self-Reported)	2.8 Measurements/week STANDARD_DEVIATION 1.31 • n=10 Participants • Only 10 participants reported the ability to perform home self-monitoring of their blood pressure at Baseline.

PRIMARY outcome

Timeframe: 8 Week

Outcome measures

Outcome measures
Measure	OWL-Hypertension 8 Wk Trial n=24 Participants Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Blood Pressure Knowledge Questionnaire	6.13 score on a scale Standard Deviation 1.23

PRIMARY outcome

Timeframe: 8 weeks

The self-efficacy instrument of the Hypertension Self-care Profile (HTN-SCP-SE) used for this study consists of 20 items assessing the respondent's confidence on a scale of 1 (Not confident) to 4 (Very confident) to regularly engage in lifestyle habits that are recommended for patients with high blood pressure. It was developed and validated in 2014. The instrument results in a total confidence/self-efficacy score ranging from 20-80, with higher scores indicating higher levels of confidence in engaging in heart-healthy lifestyle habits.

Outcome measures

Outcome measures
Measure	OWL-Hypertension 8 Wk Trial n=24 Participants Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Hypertension Self-Care Profile Self-Efficacy Instrument	65.54 score on a scale Standard Deviation 7.56

PRIMARY outcome

Timeframe: 8 Weeks

Population: One participant did not fully complete this questionnaire at baseline, resulting in 23 rather than 24 participants assessed.

The Mediterranean Diet Questionnaire (MDQ) consists of 14 yes-no items that assess participant's consumption of heart protective or harming foods. It was originally developed in Spain in 2004 to briefly assess adherence to a Mediterranean Diet and has been validated in multiple studies. Items assess the type of food eaten and whether the appropriate serving size is consumed, on a weekly basis. "Yes" responses are totaled, resulting in a score ranging from 0-14, with higher scores indicating a higher adherence to the Mediterranean Diet.

Outcome measures

Outcome measures
Measure	OWL-Hypertension 8 Wk Trial n=23 Participants Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Mediterranean Diet Questionnaire	9 score on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: 8 weeks

Population: One participant never entered a blood pressure reading in OWL-H.

To assess blood pressure self-monitoring pre-post, we first asked "Are you regularly (at least once per week) able to measure your blood pressure outside of your doctor appointments?". Those who said "yes" were then asked "How often, in a regular week, do you measure your blood pressure outside of your doctor appointments?" In their post-surveys, they were again asked to estimate their average weekly number of entries. Along with these self-report numbers, the OWL-H platform also keeps a log of every blood pressure entered by each participant across the 8 weeks.

Outcome measures

Outcome measures
Measure	OWL-Hypertension 8 Wk Trial n=23 Participants Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week	4.78 measurement per week Standard Deviation 1.90

SECONDARY outcome

Timeframe: 8 Weeks

Population: One participant never entered a blood pressure reading in OWL-H.

Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.

Outcome measures

Outcome measures
Measure	OWL-Hypertension 8 Wk Trial n=23 Participants Two groups of participants will use the Our Whole Lives - Hypertension mHealth online tool for 8 weeks each, with baseline, midpoint, and follow-up data collected to determine any change due to the intervention. OWL-Hypertension 8 Wk Trial: Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week	2.74 Measurements per week Standard Deviation 2.02

Adverse Events

OWL-Hypertension 8 Wk Trial

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

Dr. Paula Gardiner

University of Massachusetts Medical School

Phone: 7744416716

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place