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Prevalence, Awareness and Management of Hypertension in Acute Care Personnel

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT01655654
First received: July 31, 2012
Last updated: May 21, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Hypertension
Behavioral: Physical activity
Behavioral: Dietary
Other: Primary care provider visit

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevalence, Awareness and Management of Hypertension in Acute Care Personnel

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • Reduction of blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: August 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01655654

Locations
United States, Washington
Providence St. Peter Hospital
Olympia, Washington, United States, 98506
Sponsors and Collaborators
Providence Health & Services
Investigators
Principal Investigator: Dan Donahue, M.Ed. Providence Health and Services
  More Information

No publications provided

Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT01655654     History of Changes
Other Study ID Numbers: PSWR-002-EHW
Study First Received: July 31, 2012
Last Updated: May 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Providence Health & Services:
Hypertension
Acute hospital staff
Exercise
Diet

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 23, 2014