Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03974334
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : August 9, 2019
Sponsor:
Collaborators:
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
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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
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
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 27, 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 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 currently using one or more prescribed medications to treat hypertension. OWL in currently only available in English.
  • Subjects are currently receiving primary care at the adult primary care clinics at UMass Memorial Campus.
  • 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


Contacts
Layout table for location contacts
Contact: Paula Gardiner, MD 774-441-6716 paula.gardiner@umassmed.edu
Contact: Ariel Kingsley, BA 774-443-8833 ariel.kingsley@umassmed.edu

Locations
Layout table for location information
United States, Massachusetts
University of Massachusetts Medical School Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Paula Gardiner, MD    774-441-6716    paula.gardiner@umassmed.edu   
Contact: Ariel Kingsley, BA    774-443-8833    ariel.kingsley@umassmed.edu   
Sponsors and Collaborators
Paula Gardiner
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
Investigators
Layout table for investigator information
Principal Investigator: Paula Gardiner, Associate Professor, Associate Research Director, MD University of Massachusetts, Worcester

Publications:
Layout table for additonal information
Responsible Party: Paula Gardiner, Associate Professor, Associate Research Director, Medical Group Visit Program Director, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT03974334     History of Changes
Other Study ID Numbers: H00015619
U54HL143541 ( U.S. NIH Grant/Contract )
First Posted: June 4, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
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.

Layout table for additional information
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:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases