Clinical trial NCT00786162: Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Official title: Blood Pressure Self Management for Hypertension & Prehypertension Using an Internet Enabled, Automated Self Management Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 404
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 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.

Primary outcomes:
measure: Change in systolic blood pressure.
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Joseph C. Kvedar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.