Wald Outreach for Wellness: Blood Pressure Outreach

NCT04286568 | Withdrawn

• 1 other identifier: IRB00243167
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-hypertension; Hypertension

Keywords

Health Disparities; Outreach; Health Behavior; Under-served communities

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed at baseline, 6 weeks and 12 weeks

• Change in blood pressure

  Change in blood pressure (BP) measured in mmHg.

  Assessed at baseline and every 2 weeks, up to 3 months

Secondary Outcomes (3)

• Change in usage of BP monitor

  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

  Assessed at baseline, 6 weeks and 12 weeks

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

  Assessed at baseline, 6 weeks and 12 weeks

Study Arms (1)

WOW Intervention

EXPERIMENTAL

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

Interventions

WOW Intervention BEHAVIORAL

Health education and coaching, health care navigation,

WOW Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Prehypertension; Hypertension; Health Behavior

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Catherine Ling, PhD, FNP-BC

  Johns Hopkins University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: quasi-experimental non-randomized

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 22, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)