ClinicalTrials.gg
WithdrawnNCT04286568WOWUpdated Mar 22, 2023

Wald Outreach for Wellness: Blood Pressure Outreach

An interventional study of WOW Intervention in Pre-hypertension and Hypertension, sponsored by Johns Hopkins University. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-22.

Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention

Why this study was withdrawn
Disruption by Covid-19.
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 82 studies in Prehypertension with a site in United States — 6 open to participants now, 7 under way, 1 of them phase 3. Prehypertension · United States.

Enrollment
75th of 76
0 · median 60
Started
2023
with 1 other
No phase
54 of 82
2 open now
Registered
66th of 82
by date
Lead sponsor
4 of 82
Johns Hopkins University

Among the 82 studies in Prehypertension with a site in United States, this one is the 75th largest by enrollment of the 76 interventional ones that give a count, is one of 2 that started in 2023, is one of 54 with no phase, and was the 66th registered.

Prehypertension

158 studies on the registry are indexed under Prehypertension; 21 are open to participants now.

Browse Prehypertension studies →

Open to participants now

6 of the 82 studies in Prehypertension with a site in United States are open now. Recruiting first, the newest first:

1 more — sign in →

All 6 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 11 Prehypertension studies recruiting now, 3 (27%) set no upper age limit and 7 (64%) stop at 75 or younger; 3 take children under 18; 6 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 82 studies in Prehypertension with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Pre-hypertension
  • Hypertension

Keywords

  • Health Disparities
  • Outreach
  • Health Behavior
  • Under-served communities
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 17 years or younger
  • BP reading above pre-hypertensive range
  • Unable to read and understand English
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralWOW Intervention

    Health education and coaching, health care navigation,

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Assessed at baseline, 6 weeks and 12 weeks

  2. Change in blood pressure

    Change in blood pressure (BP) measured in mmHg.

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

Secondary outcomes

  1. Change in usage of BP monitor

    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

  2. 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.

    Time frame: Assessed at baseline, 6 weeks and 12 weeks

  3. 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.

    Time frame: Assessed at baseline, 6 weeks and 12 weeks

07

Study locations

1 site
  • Johns Hopkins University School of Nursing
    Baltimore, Maryland 21205, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2023; primary completion for Feb 2024, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 25, 2020
First posted
Feb 27, 2020
StartEst.
Feb 2023
Primary completionEst.
Feb 2024
CompletionEst.
Feb 2024
Last update
Mar 22, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04286568
Responsible party
Sponsor
First posted
Feb 27, 2020
Start date
Feb 2023 (estimated)
Primary completion
Feb 2024 (estimated)
Completion
Feb 2024 (estimated)
Last update
Mar 22, 2023

Study contacts

Catherine Ling, PhD, FNP-BC
principal investigator · Johns Hopkins University School of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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