Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 18, 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Blood Pressure Readings
    • Time Frame: 8 Weeks
    • Patient’s blood pressure will be taken by study staff at Baseline and Follow-Up, and by the patients at home as needed (they are asked to take it every day and input it into OWL-H) to determine if their BP has reduced during the duration of the online intervention, and to confirm if OWL-H is a successful hypertension management tool.

Secondary Measures

  • Mediterranean Diet Screener
    • Time Frame: Baseline (Week 1) and Follow-Up (Week 8) of 8 Week Study
    • A screener that evaluates patient’s intake of various foods on an average, daily basis.
  • Salt Intake Screener
    • Time Frame: Baseline (Week 1) and Follow-Up (Week 8) of 8 Week Study
    • A screener that evaluates patient’s intake of salts through eating various foods on an average basis.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Paula Gardiner
  • Collaborator
    • National Center for Advancing Translational Science (NCATS)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Paula Gardiner, Associate Professor, Associate Research Director, Medical Group Visit Program Director – University of Massachusetts, Worcester
  • Overall Official(s)
    • Paula Gardiner, Associate Professor, Associate Research Director, MD, Principal Investigator, University of Massachusetts, Worcester

References

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, 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.

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.

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