Wald Outreach for Wellness: Blood Pressure Outreach (WOW)
Primary Purpose
Pre-hypertension, Hypertension
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WOW Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Pre-hypertension focused on measuring Health Disparities, Outreach, Health Behavior, Under-served communities
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins University School of Nursing
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WOW Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in actions to control hypertension as assessed by the Behavioral Risk Factor Surveillance System Module 7
Change in yes/no answers assessed by Behavioral Risk Factor Surveillance System (BRFSS) Module 7. 10 questions graded by yes/no response.
Change in blood pressure
Change in blood pressure (BP) measured in mmHg.
Secondary Outcome Measures
Change in usage of BP monitor
Change in usage of blood pressure monitor assessed by number of BP readings done by participants.
Change in knowledge of the signs and symptoms of a heart attack and stroke as assessed by BRFSS Module 8
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.
Change in engagement with healthcare provider as assessed by BRFSS Section 3
Change in engagement with healthcare provider/medical home as assessed by BRFSS Section 3. 3 questions graded by yes/no.
Full Information
NCT ID
NCT04286568
First Posted
February 25, 2020
Last Updated
March 20, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04286568
Brief Title
Wald Outreach for Wellness: Blood Pressure Outreach
Acronym
WOW
Official Title
Wald Outreach for Wellness
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Disruption by Covid-19.
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-hypertension, Hypertension
Keywords
Health Disparities, Outreach, Health Behavior, Under-served communities
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
quasi-experimental non-randomized
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WOW Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
WOW Intervention
Intervention Description
Health education and coaching, health care navigation,
Primary Outcome Measure Information:
Title
Change in actions to control hypertension as assessed by the Behavioral Risk Factor Surveillance System Module 7
Description
Change in yes/no answers assessed by Behavioral Risk Factor Surveillance System (BRFSS) Module 7. 10 questions graded by yes/no response.
Time Frame
Assessed at baseline, 6 weeks and 12 weeks
Title
Change in blood pressure
Description
Change in blood pressure (BP) measured in mmHg.
Time Frame
Assessed at baseline and every 2 weeks, up to 3 months
Secondary Outcome Measure Information:
Title
Change in usage of BP monitor
Description
Change in usage of blood pressure monitor assessed by number of BP readings done by participants.
Time Frame
Assessed at baseline and every 2 weeks, up to 3 months
Title
Change in knowledge of the signs and symptoms of a heart attack and stroke as assessed by BRFSS Module 8
Description
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.
Time Frame
Assessed at baseline, 6 weeks and 12 weeks
Title
Change in engagement with healthcare provider as assessed by BRFSS Section 3
Description
Change in engagement with healthcare provider/medical home as assessed by BRFSS Section 3. 3 questions graded by yes/no.
Time Frame
Assessed at baseline, 6 weeks and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Ling, PhD, FNP-BC
Organizational Affiliation
Johns Hopkins University School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University School of Nursing
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Wald Outreach for Wellness: Blood Pressure Outreach
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