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

NCT00786162 | Completed

• 1 other identifier: 2006-P-002440
• Study Type: interventional
• Target: 404
• Locations: 1 country
• Sites: 1

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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Change in systolic blood pressure.

  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

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Internet-based hypertension self-management platform

Other: Internet-enabled automated self-management program

Control

ACTIVE COMPARATOR

Installation of BP cuff for communal use at the worksite

Other: BP cuff at workplace

Interventions

Internet-enabled automated self-management program OTHER

An internet platform to display blood pressure readings and provide subjects with automated messages and educational information about hypertension management.

Intervention

BP cuff at workplace OTHER

Provided BP cuff for communal use at the worksite

Control

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• 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.

  PMID: 23067923 DERIVED

Study Officials

• Joseph C. Kvedar, MD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Connected Health

Study Record Dates

• First Submitted: October 23, 2008
• First Posted: November 6, 2008
• Study Start: April 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 15, 2012

Record last verified: 2012-03

Locations

US (1)