HypertensionNCT01655654
Prevalence, Awareness and Management of Hypertension in Acute Care Personnel
A study testing Physical activity, Dietary and Primary care provider visit in people with Hypertension, run by Providence Health & Services at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Physical activity, Dietary and Primary care provider visit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2013
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Providence St. Peter Hospital
Olympia, Washington, 98506
About this study
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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Physical activity, Dietary, Primary care provider visit
- Keywords
- Hypertension, Acute hospital staff, Exercise, Diet
- Medical subject headings
- Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityBehavioural
This intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise.
DietaryBehavioural
Make at least one positive dietary change including or similar to a DASH diet snack substitution.
Primary care provider visitOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Physical activity; Behavioral: Dietary; Other: Primary care provider visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dan Donahue, M.Ed., Principal investigator, Providence Health and Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655654
- Sponsor's protocol ID
- PSWR-002-EHW
- Status last verified
- Mar 2020
- First submitted
- 31 Jul 2012
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Awareness and Management of Hypertension in Acute Care Personnel
- ClinicalTrials.gov ID
- NCT01655654
- Acronym / sponsor ID
- PSWR-002-EHW
- Conditions
- Hypertension
- Keywords
- Hypertension, Acute hospital staff, Exercise, Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 2 Aug 2012 (estimated)
- 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 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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Physical activity, Behavioral: Dietary, Other: Primary care provider visitAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Physical activityThis intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise. | Behavioural | Cohort 2 |
| DietaryMake at least one positive dietary change including or similar to a DASH diet snack substitution. | Behavioural | Cohort 2 |
| Primary care provider visitSubjects 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. | Other | Cohort 2 |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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.
Dan Donahue, M.Ed. principal investigator
Providence Health and Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity, Dietary and Primary care provider visit in people with Hypertension, run by Providence Health & Services 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 10 Mar 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction of blood pressure (time frame: 6 months). 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 10 Mar 2020.