Reducing Disparities in the Treatment of Hypertension Using the OWL mHealth Tool (OWL-H)
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|ClinicalTrials.gov Identifier: NCT03974334|
Recruitment Status : Recruiting
First Posted : June 4, 2019
Last Update Posted : August 9, 2019
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|
|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)|
|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|
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
- 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.
- 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.
- 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.
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
|Contact: Paula Gardiner, MDfirstname.lastname@example.org|
|Contact: Ariel Kingsley, BAemail@example.com|
|United States, Massachusetts|
|University of Massachusetts Medical School||Recruiting|
|Worcester, Massachusetts, United States, 01655|
|Contact: Paula Gardiner, MD 774-441-6716 firstname.lastname@example.org|
|Contact: Ariel Kingsley, BA 774-443-8833 email@example.com|
|Principal Investigator:||Paula Gardiner, Associate Professor, Associate Research Director, MD||University of Massachusetts, Worcester|