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Individually Tailored Web-Based Program to Improve Blood Pressure Control

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ClinicalTrials.gov Identifier: NCT00377208
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : February 20, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Web-Based Intervention Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Efficacy of Web-Based Feedback to Improve Blood Pressure Control
Study Start Date : January 2007
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intervention Condition
Receives web-based feedback specific to their blood-pressure and other health-related conditions.
 Behavioral: Web-Based Intervention
"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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Other markers of hypertension quality of care [ Time Frame: Measured at Year 1 ]
  2. Serum creatinine levels [ Time Frame: Measured at Year 1 ]
  3. Urine protein levels [ Time Frame: Measured at Year 1 ]
  4. Referral to a specialist when appropriate [ Time Frame: Measured at Year 1 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00377208


Locations
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United States, Pennsylvania
Penn State College of Medicine, Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Christopher N. Sciamanna, MD, MPH Penn State College of Medicine, Penn State Hershey Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Christopher Sciamanna, MD, MPH, Professor of Medicine and Public Health Sciences, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00377208    
Other Study ID Numbers: 424
05F-570
R01HL083432-01 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2006    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center:
Blood Pressure, High
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases