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

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Other: Internet-enabled automated self-management program; Other: BP cuff at workplace

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
• Enrollment (Actual): 404
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in systolic blood pressure.	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Joseph C. Kvedar, MD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: October 23, 2008
• First Submitted That Met QC Criteria: November 4, 2008
• First Posted (Estimate): November 6, 2008

Study Record Updates

• Last Update Posted (Estimate): March 15, 2012
• Last Update Submitted That Met QC Criteria: March 14, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Prehypertension
• Other Study ID Numbers: 2006-P-002440