HypertensionNCT00377208
Individually Tailored Web-Based Program to Improve Blood Pressure Control
A study testing Web-Based Intervention in people with Hypertension, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Web-Based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2007to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- Web-Based Intervention
- Keywords
- Blood Pressure, High
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based InterventionBehavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Active comparator | Receives web-based feedback specific to their blood-pressure and other health-related conditions. Receives: Behavioral: Web-Based Intervention |
| Control Condition | No intervention | The control group receives preventative feedback, general to the population. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured at Year 1
Secondary outcomes (4)
Other markers of hypertension quality of care
Measured: Measured at Year 1
Serum creatinine levels
Measured: Measured at Year 1
Urine protein levels
Measured: Measured at Year 1
Referral to a specialist when appropriate
Measured: Measured at Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Christopher Sciamanna, MD, MPH, Milton S. Hershey Medical Center
- Investigators
- Christopher N. Sciamanna, MD, MPH, Principal investigator, Penn State College of Medicine, Penn State Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00377208
- Sponsor's protocol ID
- 424
- Other IDs
- 05F-570, R01HL083432-01
- Status last verified
- Feb 2013
- First submitted
- 14 Sep 2006
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Thiboutot J, Sciamanna CN, Falkner B, Kephart DK, Stuckey HL, Adelman AM, Curry WJ, Lehman EB. Effects of a web-based patient activation intervention to overcome clinical inertia on blood pressure control: cluster randomized controlled trial. J Med Internet Res. 2013 Sep 4;15(9):e158. doi: 10.2196/jmir.2298.
PubMed 24004475
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Web-Based Feedback to Improve Blood Pressure Control
- ClinicalTrials.gov ID
- NCT00377208
- Acronym / sponsor ID
- 424
- Conditions
- Hypertension
- Keywords
- Blood Pressure, High
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Active comparator | Behavioral: Web-Based InterventionReceives web-based feedback specific to their blood-pressure and other health-related conditions. |
| Control Condition | No intervention | –The control group receives preventative feedback, general to the population. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Condition |
Primary outcome
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
4 secondary outcomes
Other markers of hypertension quality of care
Time frame: Measured at Year 1
Serum creatinine levels
Time frame: Measured at Year 1
Urine protein levels
Time frame: Measured at Year 1
Referral to a specialist when appropriate
Time frame: Measured at Year 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
- Derived from this study: PubMed 24004475Thiboutot J, Sciamanna CN, Falkner B, Kephart DK, Stuckey HL, Adelman AM, Curry WJ, Lehman EB. Effects of a web-based patient activation intervention to overcome clinical inertia on blood pressure control: cluster randomized controlled trial. J Med Internet Res. 2013 Sep 4;15(9):e158. doi: 10.2196/jmir.2298.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher N. Sciamanna, MD, MPH principal investigator
Penn State College of Medicine, Penn State Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Intervention in people with Hypertension, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00377208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.