Individually Tailored Web-Based Program to Improve Blood Pressure Control
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Health Services Research
|Official Title:||Efficacy of Web-Based Feedback to Improve Blood Pressure Control|
- 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 ] [ Designated as safety issue: No ]
- Other markers of hypertension quality of care [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Serum creatinine levels [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Urine protein levels [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
- Referral to a specialist when appropriate [ Time Frame: Measured at Year 1 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||August 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00377208
|United States, Pennsylvania|
|Penn State College of Medicine, Penn State Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|Principal Investigator:||Christopher N. Sciamanna, MD, MPH||Penn State College of Medicine, Penn State Hershey Medical Center|