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

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

Sponsors

Lead sponsor: Paula Gardiner

Collaborator: National Center for Advancing Translational Science (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
Center for Advancing Point of Care Technologies

Source University of Massachusetts, Worcester
Brief Summary

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).

Overall Status Completed
Start Date July 16, 2019
Completion Date December 18, 2019
Primary Completion Date December 18, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Blood Pressure Readings 8 Weeks
Secondary Outcome
Measure Time Frame
Mediterranean Diet Screener Baseline (Week 1) and Follow-Up (Week 8) of 8 Week Study
Salt Intake Screener Baseline (Week 1) and Follow-Up (Week 8) of 8 Week Study
Enrollment 25
Condition
Intervention

Intervention type: Behavioral

Intervention name: OWL-Hypertension 8 Wk Trial

Description: 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.

Arm group label: OWL-Hypertension 8 Wk Trial

Other name: Our Whole Lives - Hypertension

Eligibility

Criteria:

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: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paula Gardiner, Associate Professor, Associate Research Director, MD Principal Investigator University of Massachusetts, Worcester
Location
facility University of Massachusetts Medical School
Location Countries

United States

Verification Date

January 2020

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: University of Massachusetts, Worcester

Investigator full name: Paula Gardiner

Investigator title: Associate Professor, Associate Research Director, Medical Group Visit Program Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: OWL-Hypertension 8 Wk Trial

Arm group type: Experimental

Description: 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.

Acronym OWL-H
Patient Data No
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: There are 2 cohorts taking part in the same intervention at 2 separate times.

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov