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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph C. Kvedar, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00786162
First received: October 23, 2008
Last updated: March 14, 2012
Last verified: March 2012
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program

Resource links provided by NLM:


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 ]

Enrollment: 404
Study Start Date: April 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Medical School
  More Information

No publications provided by Massachusetts General Hospital

Additional 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
Study First Received: October 23, 2008
Last Updated: March 14, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Prehypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014