Individually Tailored Web-Based Program to Improve Blood Pressure Control

February 18, 2013 updated by: Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Efficacy of Web-Based Feedback to Improve Blood Pressure Control

High blood pressure affects 65 million adults in the United States, and more than one third of these individuals do not have adequate control of their blood pressure. Individuals who ask specific questions and discuss important medical issues with their doctors are more likely to receive appropriate medical care than individuals who do not. This study will evaluate the effectiveness of an interactive web site that provides individualized feedback and encourages doctor-patient communication as a way to maintain adequate blood pressure control.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High blood pressure affects a third of the United States population; it is one of the most common health problems in this country. With proper treatment, including weight loss, diet, exercise, or medication, individuals can usually maintain adequate blood pressure control. A large percentage of people, however, do not have their blood pressure under sufficient control. Prompting individuals to ask their doctors specific medical questions has proven effective in improving overall preventive medical care, but its effect on blood pressure control among hypertensive individuals has not been evaluated. "My Expert Doctor" is a web-based program that helps patients to ask the right questions regarding specific tests and treatments during their doctor visits. Upon entering medication and treatment information into the web site, patients are provided with individualized feedback and recommended questions to ask their doctor. The purpose of this study is to evaluate the effectiveness of the individualized, web-based intervention in improving blood pressure control in individuals with high blood pressure.

Both physicians and their patients will be enrolled in this 1-year study. Participating physicians will be randomly assigned to either the web-based intervention group or a control group. Recruitment materials describing the study will be mailed to their patients who have high blood pressure. Eligible patient participants will attend a baseline study visit, which will include blood pressure measurements and self-report questionnaires. Patient participants in the intervention group will receive access to the interactive section of the web site for 1 year. They will have the ability to enter their medication history, blood pressure measurements, and blood test results. This information will then be analyzed against a database containing the National Institutes of Health (NIH) blood pressure control guidelines. Questions that participants may want to ask their physician, reasons for asking the questions, and links to reputable web sites (e.g., American Heart Association) will then be displayed. Automated email reminders will encourage participants to use the web site on a monthly basis and prior to any doctor visits. Participants in the control group will be given access to an area of the web site that does not provide individualized feedback, but does contain information related to the prevention of high blood pressure. Baseline evaluations will be repeated at a Year 1 study visit. Study researchers will review participants' medical records to analyze serum creatinine test results and blood pressure measurements during the 1-year study and 1 year prior to the study.

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine, Penn State Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of hypertension
  • At least one blood pressure value that is greater than recommended in the year prior to study entry
  • An enrolled physician has provided care for managing the participant's blood pressure for at least 1 year prior to study entry
  • Access to the internet at home or at work
  • Personal email account
  • At least one blood pressure value greater than 140/90 mm Hg (130/90 mm HG for diabetes patients) in the one year prior to study entry

Exclusion Criteria:

  • Unable to speak and read English
  • Pregnant or plans to become pregnant in the year following study entry
  • Cognitively impaired
  • Currently incarcerated
  • Participating in another clinical research study
  • Planning on moving out of the area in the year following study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intervention Condition
Receives web-based feedback specific to their blood-pressure and other health-related conditions.
"My Expert Doctor" is a web-based program that helps patients to ask the right questions regarding specific tests and treatments during their doctor visits. Upon entering medication and treatment information into the web site, patients are provided with individualized feedback and recommended questions to ask their doctor.
No Intervention: Control Condition
The control group receives preventative feedback, general to the population.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with controlled blood pressure, as defined by the following criteria: less than 130/80 mm Hg for participants with diabetes or chronic kidney disease; less than 140/90 mm Hg for all other participants
Time Frame: Measured at Year 1
Measured at Year 1

Secondary Outcome Measures

Outcome Measure
Time Frame
Other markers of hypertension quality of care
Time Frame: Measured at Year 1
Measured at Year 1
Serum creatinine levels
Time Frame: Measured at Year 1
Measured at Year 1
Urine protein levels
Time Frame: Measured at Year 1
Measured at Year 1
Referral to a specialist when appropriate
Time Frame: Measured at Year 1
Measured at Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Christopher N. Sciamanna, MD, MPH, Penn State College of Medicine, Penn State Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

September 14, 2006

First Submitted That Met QC Criteria

September 14, 2006

First Posted (Estimate)

September 18, 2006

Study Record Updates

Last Update Posted (Estimate)

February 20, 2013

Last Update Submitted That Met QC Criteria

February 18, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 424
  • 05F-570
  • R01HL083432-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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