Wald Outreach for Wellness: Blood Pressure Outreach (WOW)

March 20, 2023 updated by: Johns Hopkins University

Wald Outreach for Wellness

The Wald Outreach Center will partner with Medicine for the Greater Good (MGG) to implement this pilot project called Wald Outreach for Wellness (WOW), a blood pressure outreach wellness intervention in a retail setting.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

WOW aims to provide community members with a digital blood pressure monitor, health education, and health care navigation as practical strategies to improve community members' management of pre-hypertension, and to reduce associated burdens and risks related to hypertension health disparities.

This approach to reaching populations who use retail settings has the potential to implement a health promotion and wellness strategy aimed at populations with increased risk for hypertension related health disparities. The outreach strategy is aimed at reaching community members where community members gather for health care, provide the community members with practical, low-cost strategies for promoting health and wellness, increase community members' knowledge in hypertension management, help the community members navigate health care options and get the community members engaged in a medical home thereby reducing the burdens of hypertension health disparities.

This research is important to continue to assess the best ways to reach and reduce hypertension health disparities in underserved communities with limited access to health care.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Catherine Ling, PhD, FNP-BC
  • Phone Number: 410-955-4766
  • Email: cling11@jhu.edu

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Nursing
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catherine Ling, PhD
        • Sub-Investigator:
          • Phyllis Sharps, PhD
        • Sub-Investigator:
          • Panagis Galiatsatos, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community residents who participate in Day at the Market
  • Adult individuals 18 years and older whose recorded BP reading is within the pre-hypertensive range 120-139 systolic; 80-89 diastolic
  • Able to read and understand English

Exclusion Criteria:

  • 17 years or younger
  • BP reading above pre-hypertensive range
  • Unable to read and understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WOW Intervention

Participants will receive blood pressure monitor and health passport to record blood pressure readings for 3 months.

Participants will receive daily text message reminders to take and record blood pressure readings.

Participants will receive health education and health care navigation. Participants will be assessed for social determinants of health. Participants will take surveys 3 times over 3 months. Participants will receive home visits or phone calls to collect data and receive health coaching.
Behavioral: WOW Intervention
Health education and coaching, health care navigation,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in actions to control hypertension as assessed by the Behavioral Risk Factor Surveillance System Module 7
Time Frame: Assessed at baseline, 6 weeks and 12 weeks
Change in yes/no answers assessed by Behavioral Risk Factor Surveillance System (BRFSS) Module 7. 10 questions graded by yes/no response.
Assessed at baseline, 6 weeks and 12 weeks
Change in blood pressure
Time Frame: Assessed at baseline and every 2 weeks, up to 3 months
Change in blood pressure (BP) measured in mmHg.
Assessed at baseline and every 2 weeks, up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in usage of BP monitor
Time Frame: Assessed at baseline and every 2 weeks, up to 3 months
Change in usage of blood pressure monitor assessed by number of BP readings done by participants.
Assessed at baseline and every 2 weeks, up to 3 months
Change in knowledge of the signs and symptoms of a heart attack and stroke as assessed by BRFSS Module 8
Time Frame: Assessed at baseline, 6 weeks and 12 weeks
Change in knowledge (yes/no responses) of signs and symptoms of stroke/heart attack as assessed by BRFSS Module 8. 13 Questions graded by yes/no.
Assessed at baseline, 6 weeks and 12 weeks
Change in engagement with healthcare provider as assessed by BRFSS Section 3
Time Frame: Assessed at baseline, 6 weeks and 12 weeks
Change in engagement with healthcare provider/medical home as assessed by BRFSS Section 3. 3 questions graded by yes/no.
Assessed at baseline, 6 weeks and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2023

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00243167

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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