SPHERE Hypertension Intervention Study

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00495833
First received: June 29, 2007
Last updated: June 25, 2010
Last verified: June 2010
  Purpose

Overview: This study uses communications strategies delivered through the traditional emergency medical response system to increase the proportion of low-income adults who obtain blood pressure screening and follow-up information for hypertension treatment options. The project will test the effectiveness of source personalization and tailored messaging in motivating potentially high-risk people, identified by 911 responders, to come to a local fire station for hypertension screening.

Specific Aims: The specific aims are:

  1. Test the effectiveness of three health marketing approaches to motivate high-risk people, identified via 911 responders, to come to a local fire station for hypertension screening. The mailed marketing approaches vary personalized risk information and personalization of source.
  2. Test the effectiveness of two mailing interventions (blood pressure kits with and without promotional gifts) to increase blood pressure monitoring among patients who have come to a fire station for a second blood pressure check.

Condition Intervention
Hypertension
Behavioral: Personalized brochure
Behavioral: Promotional gift

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: SPHERE Hypertension Intervention Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • The effectiveness of three health marketing approaches to motivate high-risk people, identified via 911 responders, to come to a local fire station for hypertension screening. [ Time Frame: June 2007-June 2009 ] [ Designated as safety issue: No ]
  • The effectiveness of two mailing interventions (blood pressure kits with and without promotional gifts) to increase blood pressure monitoring among patients who have come to a fire station for a second blood pressure check. [ Time Frame: June 2007 - June 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Test if non-responders have lower trust in, and/or lower perceived efficacy of, the fire stations as preventive health care providers than participants who go to the fire station for a blood pressure check. [ Time Frame: June 2007 - December 2009 ] [ Designated as safety issue: No ]
  • Correlate the resulting health behaviors with existing health disparity indicators (including health literacy, socioeconomic status, and rural residence) [ Time Frame: June 2007 - December 2009 ] [ Designated as safety issue: No ]
  • Cost analysis [ Time Frame: June 2007 - December 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 8000
Study Start Date: June 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Experimental: 2
photo and blood pressure personalization
Behavioral: Personalized brochure
either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 3
photo personalization only
Behavioral: Personalized brochure
either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 4
blood pressure personalization only
Behavioral: Personalized brochure
either photo personalization, blood pressure personalization, both, or no personalization
Experimental: 5
no personalization
Behavioral: Personalized brochure
either photo personalization, blood pressure personalization, both, or no personalization
Experimental: A
receives gift card in blood pressure (BP) kit
Behavioral: Promotional gift
half of participants who go to a fire station will receive a gift card.
Experimental: B
does not receive gift card in BP kit
Behavioral: Promotional gift
half of participants who go to a fire station will receive a gift card.

Detailed Description:

Hypertension, if left untreated, is a major risk factor for stroke, heart attack, heart failure or kidney failure. Many people with hypertension don't know they have the disease and/or may be under treated. As such they are at higher risk for health complications than those who are managing their condition.

People who see a regular healthcare provider are more likely to know they have hypertension, and they are more likely to receive appropriate treatment. However, many patients who call 9-1-1 for emergency medical services (EMS) do not have regular health care providers and may be more at risk for undiagnosed or under treated disease.

EMS personnel enter the homes of thousands of residents each year. Emergency medical technicians (EMTs) routinely take patients' blood pressure as part of their standard diagnostic procedures. EMTs and paramedics complete a medical incident report form (MIRF) for each patient, including this information. As recorded on the MIRFs, thousands of patients have high blood pressure (defined by a systolic measurement of 160 or higher and/or a diastolic measurement of 100 or higher) during those visits. Blood pressure may be elevated simply from the stress and anxiety of a 9-1-1 response. But even in light of this potential "white coat" phenomenon, blood pressure readings at these levels are very high and are a cause for concern, especially in cases where patients are not transported to the hospital for further examination.

From February - April, 2007 we are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT (SPHERE Hypertension Baseline Data Study). We want to understand what these patients remember during the 9-1-1 response around their high blood pressure measure, if the patients seek a second reading, and if the patients seek follow-up care as a result of the high blood pressure measure. We are also interested to learn if patients trust EMTs as a provider of preventive health care. This baseline data will also allow us to more accurately measure the success of this proposed intervention study. The baseline data collection is almost completed and we now will proceed with an intervention study.

We propose to conduct an intervention study next, aimed at:

  • Motivating subjects to receive a follow-up hypertension assessment from an EMT at a local fire station after receiving a high blood pressure reading from an EMT during a 911 event.
  • Motivating subjects to monitor their blood pressure as appropriate.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seen by EMTs in one of the four participating fire departments (Bellevue, Kent, Renton, Shoreline)
  • Recorded systolic blood pressure >= 160 and/or diastolic blood pressure >= 100
  • At least 18 years old

Exclusion Criteria:

  • Patient transported by paramedics
  • Patient nursing home/adult family home resident
  • Patient a prisoner or in custody (in jail or at the Regional Justice Center in Kent, for example)
  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: NCT00495833

Locations
United States, Washington
University of Washington Health Promotion Research Center
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Hendrika Meischke, PhD University of Washington
Principal Investigator: Mickey Eisenberg, MD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hendrika Meischke, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT00495833     History of Changes
Other Study ID Numbers: 32168-E/G, 07-6656-E/G 01
Study First Received: June 29, 2007
Last Updated: June 25, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 22, 2014