- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01655654
Prevalence, Awareness and Management of Hypertension in Acute Care Personnel
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Research on hypertension (HTN) in hospital personnel during work hours is limited yet research has been published on the relationship of job strain and the risk of cardiovascular disease. HTN can be caused by sympathoadrenal activation brought on by long-term exposure to stressors and an inherent biomarker that is associated with an increased risk of cardiovascular disease.
The primary purpose of this study is to quantify differences in HTN prevalence, awareness and management in three distinctly different areas and shifts within an acute hospital. Blood pressure (BP) will be taken during working hours along with pre and post sleep hours. The secondary purpose is to identify the effect of shift work within an acute care hospital and effectiveness of: BP monitoring, increases in physical activity, positive nutritional changes, and the correlation between a primary care provider visits and lowering BP.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Olympia, Washington, United States, 98506
- Providence St. Peter Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Providence Health System's Southwest Washington Service Area (SWSA) employees
- Subjects who will be included in the intervention part of the study will have two consecutive BP readings of > 140/90
- Has or is willing to have collaborative PCP
- Understand and sign the informed consent form
Exclusion Criteria:
- Under the age of 18
- Has a severe systemic illness with life expectancy judged less than three years
- Has a severe vascular event such as Myocardial Infarction or Cerebral Vascular Event in the past 90 days
- Is enrolled in another therapeutic program or similar study, and
- Has a condition which, in the opinion of the investigators, may prevent the subject from participating in the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Cohort 1
All employees within the acute care hospital that signed the informed consent form and provided their individual data.
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Active Comparator: Cohort 2
All subjects of cohort 1 who also are considered hypertensive and participated in one or more study interventions, which include behavioral interventions (an increase in physical activity, or dietary changes) or who have a primary care provider visit to discuss hypertension.
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This intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise.
Make at least one positive dietary change including or similar to a DASH diet snack substitution.
Subjects with hypertension will be asked to visit their primary care provider seeking treatment options.
If a subject does not have a primary care provider then they will be encouraged to obtain one and seek medical treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of blood pressure
Time Frame: 6 months
|
The study will look for a reduction in blood pressure during a 6-month time frame among those identified at screening to have high blood pressure and who continue on in the study.
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6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dan Donahue, M.Ed., Providence Health and Services
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSWR-002-EHW
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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