Blood PressureNCT00786162
Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
A study testing Internet-enabled automated self-management program and BP cuff at workplace in people with Blood Pressure, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Internet-enabled automated self-management program and BP cuff at workplace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2008
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Full-time employees of EMC
- Aged 30 to 65 years at time of enrollment
- Any of the following
- A diagnosis of hypertension as defined by one of the following
- Taking an antihypertensive medication
- Being told at least twice by a physician or other health professional that the subject has high blood pressure†
Show all 9Show fewer
- A BP > 140/90 detected at screening by the research team on 2 separate occasions.
- A diagnosis of prehypertension as defined by a systolic BP between 120-139 or a diastolic BP between 80-89 detected at screening by the research team on 2 separate occasions
- Access to the Internet at work and / or at home
Who cannot join
- Inability to self-monitor blood pressure due to musculoskeletal or cognitive impairment
- Known secondary cause of hypertension e.g. renal artery stenosis, Cushing's disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.
Read the detailed description
We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites.
Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback.
Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback.
The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure.
- Conditions
- Blood Pressure
- Being tested
- Internet-enabled automated self-management program, BP cuff at workplace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-enabled automated self-management programOther
An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.
BP cuff at workplaceOther
Provided BP cuff for communal use at the worksite
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Internet-based hypertension self-management platform Receives: Other: Internet-enabled automated self-management program |
| Control | Active comparator | Installation of BP cuff for communal use at the worksite Receives: Other: BP cuff at workplace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure.
Measured: 6 months
Secondary outcomes (1)
Assess whether the intervention increases the motivation and self-efficacy of patients managing blood pressure. Assess patient satisfaction with the intervention. Assess the impact of the intervention on healthcare utilization and expenditure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2008
- Study completionDec 2008
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 Blood PressureStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph C. Kvedar, Massachusetts General Hospital
- Investigators
- Joseph C. Kvedar, MD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786162
- Sponsor's protocol ID
- 2006-P-002440
- Status last verified
- Mar 2012
- First submitted
- 23 Oct 2008
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Watson AJ, Singh K, Myint-U K, Grant RW, Jethwani K, Murachver E, Harris K, Lee TH, Kvedar JC. Evaluating a web-based self-management program for employees with hypertension and prehypertension: a randomized clinical trial. Am Heart J. 2012 Oct;164(4):625-31. doi: 10.1016/j.ahj.2012.06.013.
PubMed 23067923
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
- ClinicalTrials.gov ID
- NCT00786162
- Acronym / sponsor ID
- 2006-P-002440
- Conditions
- Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 6 Nov 2008 (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.
The specific aim of the study is to assess the impact of an Internet-enabled, automated, self-management program on blood pressure control of employees of a large local company.
Detailed description
We propose to conduct a randomized controlled trial of an Internet-enabled, automated self-management program. The study will be carried out through six local sites (offices) of a large employer. 3 sites will be intervention sites and 3 will be control sites.
Subjects enrolled from the intervention sites will receive a blood pressure meter and access to an Internet site where they can view their readings, read educational material regarding hypertension management and receive personalized tips and feedback.
Subjects enrolled from the control sites will have access to a blood pressure monitor located at their workplace but will only be provided with basic written information about hypertension at the start of the trial and will receive no feedback.
The trial will run for 6 months from the time of enrollment and the primary outcome measure will be a change in systolic blood pressure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Internet-enabled automated self-management programInternet-based hypertension self-management platform |
| Control | Active comparator | Other: BP cuff at workplaceInstallation of BP cuff for communal use at the worksite |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Full-time employees of EMC
- Aged 30 to 65 years at time of enrollment
- Any of the following
- A diagnosis of hypertension as defined by one of the following
- Taking an antihypertensive medication
Key exclusion criteria (2 listed)
- Inability to self-monitor blood pressure due to musculoskeletal or cognitive impairment
- Known secondary cause of hypertension e.g. renal artery stenosis, Cushing's disease.
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 |
|---|---|---|
| Internet-enabled automated self-management programAn internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management. | Other | Intervention |
| BP cuff at workplaceProvided BP cuff for communal use at the worksite | Other | Control |
Primary outcome
Change in systolic blood pressure.
Time frame: 6 months
1 secondary outcome
Assess whether the intervention increases the motivation and self-efficacy of patients managing blood pressure. Assess patient satisfaction with the intervention. Assess the impact of the intervention on healthcare utilization and expenditure
Time frame: 6 months
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 15 Mar 2012.
- Derived from this study: PubMed 23067923Watson AJ, Singh K, Myint-U K, Grant RW, Jethwani K, Murachver E, Harris K, Lee TH, Kvedar JC. Evaluating a web-based self-management program for employees with hypertension and prehypertension: a randomized clinical trial. Am Heart J. 2012 Oct;164(4):625-31. doi: 10.1016/j.ahj.2012.06.013.
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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.
Joseph C. Kvedar, MD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-enabled automated self-management program and BP cuff at workplace in people with Blood Pressure, run by Massachusetts General Hospital 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 9 inclusion and 2 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 15 Mar 2012. 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?
Change in systolic blood pressure. (time frame: 6 months). 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 NCT00786162, 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 15 Mar 2012.