Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool (OWL-H)

This is a one-year study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure.

Specific Aim 1 - To pilot test the OWL-H platform for 8 weeks with 26 patients with hypertension (2 groups of 13) to refine its utility for home self-monitoring (number of times patients record home blood pressure and input this data onto OWL-H and engagement of self-management (i.e. # of logins, # of mind body sessions completed, # of times modules accessed each day)). Hypothesis 1: Eighty percent of patients will log in and record their blood pressures.

Specific Aim 2 - At the end of each group, hold a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors (e.g., smoking, eating habits, perceived stress, and amount of exercise and health-related quality of life).

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: OWL-Hypertension 8 Wk Trial

Detailed Description

This is a one-year pre post clinical study. The study's primary outcome is successful improvement of the Our Whole Lives for Hypertension (OWL-H) online patient education platform, based upon participant use and focus group feedback, to deliver information on self-management of hypertension and other cardiac risk factors, and to encourage self-monitoring of blood pressure. We piloted online OWL-H platform for 8 weeks with 26 patients with hypertension to refine its utility for home self-monitoring. We also held a focus group to obtain information about: 1) the barriers and facilitators of using the OWL-H platform and using OWL-H to self-monitor blood pressure at home, 2) satisfaction with OWL-H, 3) how OWL-H helped with reduction of number of cardiac risk factors

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female subjects of all races and ethnicities who are English-speaking adults over the age of 18 and who have a current diagnosis of hypertension.. OWL in currently only available in English.
• Subjects' physical and mental health status will be sufficient to be able to comprehend instructions and participate in the interventions.
• Subjects must be able to access computer technology (cellular phone, desktop, laptop) and the internet to utilize the online OWL-H.

Exclusion Criteria:

• Serious underlying systemic or co-morbid disease, including psychotic or manic symptoms, which preclude physical or cognitive ability to participate in the intervention.

The risk-benefit ratio of the interventions for these individuals may be potentially higher than acceptable.

• Active substance abuse, given that individuals who have active substance abuse pose a higher risk both to themselves and other members of the groups.
• Beginning new hypertension treatments in the past week or planning to begin new hypertension treatments in the next few weeks, or planning a major medical event in the next few weeks, which would interfere with accurately determining the effect of the intervention on impact in this study.
• Subjects who are pregnant will be not included in this study given that the risk-benefit ratio of this intervention may be higher than acceptable for these individuals due to the potential onset of non-study related gestational diabetes and/or gestational hypertension. Determination of pregnancy status will be based upon subject self-report.
• Subjects who are not willing to participate in the intervention or attend the group visits.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: OWL-Hypertension 8 Wk Trial; 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.

Behavioral: 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.; Other Names: Our Whole Lives - Hypertension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure Knowledge Questionnaire	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.	8 Week
Hypertension Self-Care Profile Self-Efficacy Instrument	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.	8 weeks
Mediterranean Diet Questionnaire	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.	8 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week	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.	8 weeks
Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week	Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.	8 Weeks

Collaborators and Investigators

• Sponsor: Paula Gardiner
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); University of Massachusetts, Worcester; National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Paula Gardiner, Associate Professor, Associate Research Director, MD, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• Gardiner P, Dresner D, Barnett KG, Sadikova E, Saper R. Medical group visits: a feasibility study to manage patients with chronic pain in an underserved urban clinic. Glob Adv Health Med. 2014 Jul;3(4):20-6. doi: 10.7453/gahmj.2014.011.
• Bartolome RE, Chen A, Handler J, Platt ST, Gould B. Population Care Management and Team-Based Approach to Reduce Racial Disparities among African Americans/Blacks with Hypertension. Perm J. 2016 Winter;20(1):53-9. doi: 10.7812/TPP/15-052.
• Fang J, Yang Q, Ayala C, Loustalot F. Disparities in access to care among US adults with self-reported hypertension. Am J Hypertens. 2014 Nov;27(11):1377-86. doi: 10.1093/ajh/hpu061. Epub 2014 May 21.
• Gardiner P, Lestoquoy AS, Gergen-Barnett K, Penti B, White LF, Saper R, Fredman L, Stillman S, Lily Negash N, Adelstein P, Brackup I, Farrell-Riley C, Kabbara K, Laird L, Mitchell S, Bickmore T, Shamekhi A, Liebschutz JM. Design of the integrative medical group visits randomized control trial for underserved patients with chronic pain and depression. Contemp Clin Trials. 2017 Mar;54:25-35. doi: 10.1016/j.cct.2016.12.013. Epub 2016 Dec 13.
• Gardiner P, McGonigal L, Villa A, Kovell LC, Rohela P, Cauley A, Rinker D, Olendzki B. Our Whole Lives for Hypertension and Cardiac Risk Factors-Combining a Teaching Kitchen Group Visit With a Web-Based Platform: Feasibility Trial. JMIR Form Res. 2022 May 16;6(5):e29227. doi: 10.2196/29227.
• Rohela P, Olendzki B, McGonigal LJ, Villa A, Gardiner P. A Teaching Kitchen Medical Groups Visit with an eHealth Platform for Hypertension and Cardiac Risk Factors: A Qualitative Feasibility Study. J Altern Complement Med. 2021 Nov;27(11):974-983. doi: 10.1089/acm.2021.0148. Epub 2021 Aug 5.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2019
• Primary Completion (Actual): December 18, 2019
• Study Completion (Actual): December 18, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 4, 2019

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Blood Pressure, High
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: H00015619; 5U54HL143541-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data being collected is based on an intervention that is changing from cohort focus group to cohort focus group. It is also small sample size (n = 26) and only pilot data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No