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

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ClinicalTrials.gov Identifier: NCT03974334
Recruitment Status : Completed
First Posted : June 4, 2019
Results First Posted : February 24, 2021
Last Update Posted : February 24, 2021
Sponsor:
Collaborators:
National Center for Advancing Translational Science (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
University of Massachusetts, Worcester
Information provided by (Responsible Party):
Paula Gardiner, 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).


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: OWL-Hypertension 8 Wk Trial Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool
Actual Study Start Date : July 16, 2019
Actual Primary Completion Date : December 18, 2019
Actual Study Completion Date : December 18, 2019

Resource links provided by the National Library of Medicine


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 Name: Our Whole Lives - Hypertension




Primary Outcome Measures :
  1. Blood Pressure Knowledge Questionnaire [ Time Frame: 8 Week ]
    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.

  2. Hypertension Self-Care Profile Self-Efficacy Instrument [ Time Frame: 8 weeks ]
    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.

  3. Mediterranean Diet Questionnaire [ Time Frame: 8 Weeks ]
    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.


Secondary Outcome Measures :
  1. Numbers of Time Blood Pressure Self-Monitoring Occurred During One Week [ Time Frame: 8 weeks ]
    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.

  2. Number of Time Blood Pressure Self-Monitoring on the OWL Platform Occurred Per Week [ Time Frame: 8 Weeks ]
    Actual mean weekly entries of blood pressure readings in the OWL-H platform across the 8 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974334


Locations
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United States, Massachusetts
University of Massachusetts Medical School
Worcester, Massachusetts, United States, 01655
Sponsors and Collaborators
Paula Gardiner
National Center for Advancing Translational Science (NCATS)
National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)
University of Massachusetts, Worcester
Investigators
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Principal Investigator: Paula Gardiner, Associate Professor, Associate Research Director, MD University of Massachusetts, Worcester
  Study Documents (Full-Text)

Documents provided by Paula Gardiner, University of Massachusetts, Worcester:
Study Protocol  [PDF] August 14, 2020
Statistical Analysis Plan  [PDF] August 14, 2020
Informed Consent Form  [PDF] August 14, 2020

Publications:
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Responsible Party: Paula Gardiner, Associate Professor, Associate Research Director, Medical Group Visit Program Director, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03974334    
Other Study ID Numbers: H00015619
5U54HL143541-03 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2019    Key Record Dates
Results First Posted: February 24, 2021
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paula Gardiner, University of Massachusetts, Worcester:
Blood Pressure, High
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases