Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program - Full Text View

Sponsored by:	Massachusetts General Hospital
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00786162

Purpose

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	Intervention
Blood Pressure	Other: Internet-enabled automated self-management program Other: BP cuff at workplace

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

Change in systolic blood pressure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	402
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intervention: Experimental 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.
Control: Active Comparator Installation of BP cuff for communal use at the worksite	Other: BP cuff at workplace Provided BP cuff for communal use at the worksite

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.

Eligibility

Ages Eligible for Study:	30 Years to 65 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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 University

More Information

Responsible Party:	Massachusetts General Hospital ( Joseph Kvedar )
Study ID Numbers:	2006-P-002440
Study First Received:	October 23, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00786162
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009