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Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool | Clinical Trials | Clareo Health

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

NCT03974334•Paula Gardiner

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).

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Key Dates

Start Date

July 16, 2019

Primary Completion Date

December 18, 2019

Completion Date

December 18, 2019

Last Updated

February 24, 2021

Enrollment

ACTUAL participants

Conditions

Hypertension

Interventions

OWL-Hypertension 8 Wk Trial

BEHAVIORAL

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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Pulmonary Hypertension

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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