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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-16

Study Completion Date

2019-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Remote Patient Monitoring and Health Coaching vs. Usual Care for the Treatment of Hypertension

NCT05394766

Hypertension

RECRUITING NA

Leveraging Electronic Health Record (EHR) Tools to Reduce Health Disparities for Patients With Uncontrolled Hypertension

NCT05030467

Hypertension Blood Pressure

COMPLETED NA

Individually Tailored Web-Based Program to Improve Blood Pressure Control

NCT00377208

Hypertension

COMPLETED NA

An Artificial Intelligence-Assisted Digital Health Lifestyle Intervention for Adults With Hypertension

NCT06337734

Hypertension

COMPLETED NA

Efficacy of Education Via Phone-based Text Messaging (SMS) on Patients With Uncontrolled Hypertension

NCT05711004

Hypertension

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

There are 2 cohorts taking part in the same intervention at 2 separate times.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

OWL-Hypertension 8 Wk Trial

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Our Whole Lives - Hypertension

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No