NCT00377208

Brief Summary

High blood pressure affects 65 million adults in the United States, and more than one third of these individuals do not have adequate control of their blood pressure. Individuals who ask specific questions and discuss important medical issues with their doctors are more likely to receive appropriate medical care than individuals who do not. This study will evaluate the effectiveness of an interactive web site that provides individualized feedback and encourages doctor-patient communication as a way to maintain adequate blood pressure control.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 18, 2006

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

3.6 years

First QC Date

September 14, 2006

Last Update Submit

February 18, 2013

Conditions

Hypertension

Keywords

Blood Pressure, High

Outcome Measures

Primary Outcomes (1)

  • Percentage of participants with controlled blood pressure, as defined by the following criteria: less than 130/80 mm Hg for participants with diabetes or chronic kidney disease; less than 140/90 mm Hg for all other participants

    Measured at Year 1

Secondary Outcomes (4)

  • Other markers of hypertension quality of care

    Measured at Year 1

  • Serum creatinine levels

    Measured at Year 1

  • Urine protein levels

    Measured at Year 1

  • Referral to a specialist when appropriate

    Measured at Year 1

Study Arms (2)

Intervention Condition

ACTIVE COMPARATOR

Receives web-based feedback specific to their blood-pressure and other health-related conditions.

Behavioral: Web-Based Intervention

Control Condition

NO INTERVENTION

The control group receives preventative feedback, general to the population.

Interventions

Web-Based InterventionBEHAVIORAL

"My Expert Doctor" is a web-based program that helps patients to ask the right questions regarding specific tests and treatments during their doctor visits. Upon entering medication and treatment information into the web site, patients are provided with individualized feedback and recommended questions to ask their doctor.

Intervention Condition

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of hypertension
  • At least one blood pressure value that is greater than recommended in the year prior to study entry
  • An enrolled physician has provided care for managing the participant's blood pressure for at least 1 year prior to study entry
  • Access to the internet at home or at work
  • Personal email account
  • At least one blood pressure value greater than 140/90 mm Hg (130/90 mm HG for diabetes patients) in the one year prior to study entry

You may not qualify if:

  • Unable to speak and read English
  • Pregnant or plans to become pregnant in the year following study entry
  • Cognitively impaired
  • Currently incarcerated
  • Participating in another clinical research study
  • Planning on moving out of the area in the year following study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (1)

  • Thiboutot J, Sciamanna CN, Falkner B, Kephart DK, Stuckey HL, Adelman AM, Curry WJ, Lehman EB. Effects of a web-based patient activation intervention to overcome clinical inertia on blood pressure control: cluster randomized controlled trial. J Med Internet Res. 2013 Sep 4;15(9):e158. doi: 10.2196/jmir.2298.

    PMID: 24004475DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Christopher N. Sciamanna, MD, MPH

    Penn State College of Medicine, Penn State Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Public Health Sciences

Study Record Dates

First Submitted

September 14, 2006

First Posted

September 18, 2006

Study Start

January 1, 2007

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

US(1)