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Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program

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ClinicalTrials.gov Identifier: NCT00786162
Recruitment Status : Completed
First Posted : November 6, 2008
Last Update Posted : March 15, 2012
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Other: Internet-enabled automated self-management program Other: BP cuff at workplace Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 404 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Study Start Date : April 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: Intervention
Internet-based hypertension self-management platform
Other: Internet-enabled automated self-management program
An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.
Active Comparator: Control
Installation of BP cuff for communal use at the worksite
Other: BP cuff at workplace
Provided BP cuff for communal use at the worksite



Primary Outcome Measures :
  1. Change in systolic blood pressure. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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†
  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00786162


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Joseph C. Kvedar, MD Harvard Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joseph C. Kvedar, Director, Center for Connected Health, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00786162     History of Changes
Other Study ID Numbers: 2006-P-002440
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases