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SPHERE Hypertension Intervention Study

University of Washington logo

University of Washington

Status

Completed

Conditions

Hypertension

Treatments

Behavioral: Promotional gift
Behavioral: Personalized brochure

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00495833
32168-E/G
07-6656-E/G 01

Details and patient eligibility

About

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.

Full 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.

Enrollment

8,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

8,000 participants in 7 patient groups

1
No Intervention group
2
Experimental group
Description:
photo and blood pressure personalization
Treatment:
Behavioral: Personalized brochure
3
Experimental group
Description:
photo personalization only
Treatment:
Behavioral: Personalized brochure
4
Experimental group
Description:
blood pressure personalization only
Treatment:
Behavioral: Personalized brochure
5
Experimental group
Description:
no personalization
Treatment:
Behavioral: Personalized brochure
A
Experimental group
Description:
receives gift card in blood pressure (BP) kit
Treatment:
Behavioral: Promotional gift
B
Experimental group
Description:
does not receive gift card in BP kit
Treatment:
Behavioral: Promotional gift

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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