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WOW: Wald Outreach for Wellness: Blood Pressure Outreach

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04286568
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
12
Anticipated Duration (Months)
3.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: WOW Intervention
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
quasi-experimental non-randomizedquasi-experimental non-randomized
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Wald Outreach for Wellness
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

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,

Outcome Measures

Primary Outcome Measures

  1. Change in actions to control hypertension as assessed by the Behavioral Risk Factor Surveillance System Module 7 [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.

  2. Change in blood pressure [Assessed at baseline and every 2 weeks, up to 3 months]

    Change in blood pressure (BP) measured in mmHg.

Secondary Outcome Measures

  1. Change in usage of BP monitor [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.

  2. Change in knowledge of the signs and symptoms of a heart attack and stroke as assessed by BRFSS Module 8 [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.

  3. Change in engagement with healthcare provider as assessed by BRFSS Section 3 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins University School of Nursing Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins University

Investigators

  • Principal Investigator: Catherine Ling, PhD, FNP-BC, Johns Hopkins University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT04286568
Other Study ID Numbers:
  • IRB00243167
First Posted:
Feb 27, 2020
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Johns Hopkins University
Health Disparities
Outreach
Health Behavior
Under-served communities
Additional relevant MeSH terms:
Hypertension
Prehypertension

Study Results

No Results Posted as of Aug 25, 2022