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OpenTrials
Completed

NCT Number: NCT00786162

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.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

BP cuff at workplace

Other

Provided BP cuff for communal use at the worksite

Primary outcomes

  1. Change in systolic blood pressure.

    Time frame: 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

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Nov 6, 2008
Registry last updated
Mar 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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