Pre-hypertensionWOWNCT04286568
Wald Outreach for Wellness: Blood Pressure Outreach
A study testing WOW Intervention in people with Pre-hypertension and Hypertension, run by Johns Hopkins University at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pre-hypertension, Hypertension
- What is being tested?
- WOW Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 17 years or younger
- BP reading above pre-hypertensive range
- Unable to read and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: 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.
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.
- Conditions
- Pre-hypertension, Hypertension
- Being tested
- WOW Intervention
- Keywords
- Health Disparities, Outreach, Health Behavior, Under-served communities
- Medical subject headings
- Prehypertension, Hypertension, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOW InterventionBehavioural
Health education and coaching, health care navigation,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: WOW Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at baseline, 6 weeks and 12 weeks
Change in blood pressure
Change in blood pressure (BP) measured in mmHg.
Measured: Assessed at baseline and every 2 weeks, up to 3 months
Secondary outcomes (3)
Change in usage of BP monitor
Change in usage of blood pressure monitor assessed by number of BP readings done by participants.
Measured: 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
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.
Measured: Assessed at baseline, 6 weeks and 12 weeks
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.
Measured: Assessed at baseline, 6 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study startFeb 2023 (estimated)
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Why it stopped: Disruption by Covid-19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- quasi-experimental non-randomized
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Ling, PhD, FNP-BC, Principal investigator, Johns Hopkins University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04286568
- Sponsor's protocol ID
- IRB00243167
- Acronym
- WOW
- Status last verified
- Aug 2022
- First submitted
- 25 Feb 2020
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wald Outreach for Wellness
- ClinicalTrials.gov ID
- NCT04286568
- Acronym / sponsor ID
- WOW / IRB00243167
- Conditions
- Pre-hypertension, Hypertension
- Keywords
- Health Disparities, Outreach, Health Behavior, Under-served communities
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Disruption by Covid-19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Feb 2023 (estimated)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- quasi-experimental non-randomized
| Arm | Type | Receives |
|---|---|---|
| WOW Intervention | Experimental | Behavioral: WOW InterventionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 17 years or younger
- BP reading above pre-hypertensive range
- Unable to read and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WOW InterventionHealth education and coaching, health care navigation, | Behavioural | WOW Intervention |
Primary outcome
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.
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.
3 secondary outcomes
Change in usage of BP monitor
Time frame: 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 engagement with healthcare provider as assessed by BRFSS Section 3
Time frame: Assessed at baseline, 6 weeks and 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Pre-hypertension
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Ling, PhD, FNP-BC principal investigator
Johns Hopkins University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WOW Intervention in people with Pre-hypertension and Hypertension, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2023.