Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Tracking Information | |||||
---|---|---|---|---|---|
First Received Date ICMJE | October 23, 2008 | ||||
Last Updated Date | March 14, 2012 | ||||
Start Date ICMJE | April 2007 | ||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in systolic blood pressure. [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00786162 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program | ||||
Official Title ICMJE | Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program | ||||
Brief 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. |
||||
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 Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
||||
Condition ICMJE | Blood Pressure | ||||
Intervention ICMJE |
|
||||
Study Arm (s) |
|
||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 404 | ||||
Completion Date | December 2008 | ||||
Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
Gender | Both | ||||
Ages | 30 Years to 65 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00786162 | ||||
Other Study ID Numbers ICMJE | 2006-P-002440 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Joseph C. Kvedar, Massachusetts General Hospital | ||||
Study Sponsor ICMJE | Massachusetts General Hospital | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
|
||||
Information Provided By | Massachusetts General Hospital | ||||
Verification Date | March 2012 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |