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

October 23, 2008
March 14, 2012
April 2007
December 2008   (final data collection date for primary outcome measure)
Change in systolic blood pressure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786162 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
 
 
Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
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.

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.

Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Blood Pressure
  • 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.
  • Other: BP cuff at workplace
    Provided BP cuff for communal use at the worksite
  • Experimental: Intervention
    Internet-based hypertension self-management platform
    Intervention: Other: Internet-enabled automated self-management program
  • Active Comparator: Control
    Installation of BP cuff for communal use at the worksite
    Intervention: Other: BP cuff at workplace
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
404
December 2008
December 2008   (final data collection date for primary outcome measure)

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.
Both
30 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00786162
2006-P-002440
No
Joseph C. Kvedar, Massachusetts General Hospital
Massachusetts General Hospital
 
Principal Investigator: Joseph C. Kvedar, MD Harvard University
Massachusetts General Hospital
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP