NCT01655654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

July 31, 2012

Last Update Submit

March 7, 2020

Conditions

Keywords

HypertensionAcute hospital staffExerciseDiet

Outcome Measures

Primary Outcomes (1)

  • Reduction of blood pressure

    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.

    6 months

Study Arms (2)

Cohort 1

NO INTERVENTION

All employees within the acute care hospital that signed the informed consent form and provided their individual data.

Cohort 2

ACTIVE COMPARATOR

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 activityBehavioral: DietaryOther: Primary care provider visit

Interventions

This intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise.

Cohort 2
DietaryBEHAVIORAL

Make at least one positive dietary change including or similar to a DASH diet snack substitution.

Cohort 2

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.

Cohort 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Providence St. Peter Hospital

Olympia, Washington, 98506, United States

Location

MeSH Terms

Conditions

HypertensionMotor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Dan Donahue, M.Ed.

    Providence Health and Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2012

First Posted

August 2, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

March 10, 2020

Record last verified: 2020-03

Locations