Prevalence, Awareness and Management of Hypertension in Acute Care Personnel

Tracking Information
First Submitted Date ICMJE	July 31, 2012
First Posted Date ICMJE	August 2, 2012
Last Update Posted Date	May 22, 2013
Study Start Date ICMJE	August 2012
Estimated Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: July 31, 2012)	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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01655654 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Prevalence, Awareness and Management of Hypertension in Acute Care Personnel
Official Title ICMJE	Prevalence, Awareness and Management of Hypertension in Acute Care Personnel
Brief Summary	The primary purpose of this study is to identify the percentage of health care workers working in an acute care hospital who have high blood pressure, to determine the awareness of their blood pressure status, and to see how well it is managed. Study participants will come from the following three distinctly different types of departments: telemetry (clinical), non-telemetry (clinical), and non-direct patient care staff. All study participants are offered educational information surrounding high blood pressure and review the recommendation for their primary care engagement. Study participants with high blood pressure will be asked to continue in the study for up to 6 months. It is intended that each study participant who continues will take their blood pressure three times a day and record the results in a study provided diary. Each study participant should also make some of the suggested changes that promote a healthier lifestyle including exercising, improving their diet, and seeing their primary care provider. It is the thought that these changes will reduce the study participant's blood pressure. The secondary purpose is to determine the effect shift work has on these hospital employees and the potential positive effects of the three interventions.
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 ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Hypertension
Intervention ICMJE	Behavioral: Physical activity This intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise.; Behavioral: Dietary Make at least one positive dietary change including or similar to a DASH diet snack substitution.; Other: Primary care provider visit 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.
Study Arms	No Intervention: Cohort 1 All employees within the acute care hospital that signed the informed consent form and provided their individual data.; 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. Interventions: Behavioral: Physical activity Behavioral: Dietary Other: Primary care provider visit
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: July 31, 2012)	160
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	July 2013
Estimated Primary Completion Date	July 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01655654
Other Study ID Numbers ICMJE	PSWR-002-EHW
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Providence Health & Services
Study Sponsor ICMJE	Providence Health & Services
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Dan Donahue, M.Ed. Providence Health and Services
PRS Account	Providence Health & Services
Verification Date	May 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP