- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00377208
Individually Tailored Web-Based Program to Improve Blood Pressure Control
Efficacy of Web-Based Feedback to Improve Blood Pressure Control
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Hershey, Pennsylvania, United States, 17033
- Penn State College of Medicine, Penn State Hershey Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher N. Sciamanna, MD, MPH, Penn State College of Medicine, Penn State Hershey Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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