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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00786162
• Other study ID #: 2006-P-002440
• Status: Completed
• Phase: N/A
• First received: October 23, 2008
• Last updated: March 14, 2012
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Blood Pressure
• Prehypertension

Intervention

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.
• BP cuff at workplace
Provided BP cuff for communal use at the worksite

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in systolic blood pressure.		6 months	No
Secondary	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	No