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Using an Electronic Personal Health Record to Empower Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT01317537
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : March 17, 2011
Information provided by:

Study Description
Brief Summary:

Project Summary:

An electronic personal health record (ePHR) could maximize patient/clinician collaboration and consequently improve patient self-management and related health outcomes. The purpose of the proposed project is to examine the feasibility, acceptability, and impact of an ePHR that has been modified using a patient- and family-centered approach and incorporates the experiences, perspectives, and insights of patients and family members actually using the system. Comparison of patients with the ePHR intervention to a group of "care as usual" patients will be performed. The investigators Specific Aims are: (1) To improve the application of patient- and family-centered care elements in an existing ePHR, based on feedback from a pilot study of patients and their families. The modified ePHR will be tested in a pilot group of patients with hypertension and their families. (2) To implement and test the effectiveness of the modified ePHR with patients being treated for hypertension by a team of physicians, mid-level practitioners, nurse clinicians, and support staff in two ambulatory settings. Outcome measures will include patient activation and perception of care, quantifiable biological markers, patient-physician communication, and congruence of treatment with guidelines, particularly medication management; (3) To monitor the shift in provider and support staff awareness and incorporation of patient- and family-centered care as a result of implementation of the ePHR using questionnaires and focus groups. If successful, this ePHR could be implemented in additional locations in the Southeast.

Condition or disease Intervention/treatment
Hypertension Other: Electronic personal health record

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 445 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Official Title: Using an Electronic Personal Health Record to Empower Patients With Hypertension
Study Start Date : September 2007
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Received personal health record
received personal health record access
Other: Electronic personal health record
No Intervention: No personal health record
did not receive personal health record

Outcome Measures

Primary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 9 months ]
    2 seated measures taken using manual sphygmometer by trained research associate

  2. Diastolic blood pressure [ Time Frame: 9 months ]
    2 seated measures taken using manual sphygmometer by trained research associate

Secondary Outcome Measures :
  1. patient activation [ Time Frame: 9 months ]
    Patients complete the validated paper-and-pencil Patient Activation Measure (PAM) developed by Judy Hibbard. The instrument assesses the degree to which a patient is "activated," that is the degree to which they are an active agent in their own health care, e.g. ask questions of their health care provider.

  2. Patient satisfaction with care [ Time Frame: 9 months ]
    Consumer Assessment of Health care--group and clinician survey Patient assessment of chronic care Post study interviews

  3. adherence to guidelines [ Time Frame: 9 months ]
    chart audit of patient care

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • age 21
  • hypertension
  • referral by physician

Exclusion Criteria:

  • age over 80
  • no hypertension
  • too ill to participate
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317537

United States, Georgia
Georgia Health Sciences University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Agency for Healthcare Research and Quality (AHRQ)
Cerner Corporation
The Institute for Patient- and Family-Centered Care
Principal Investigator: Peggy J Wagner, PhD Augusta University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peggy J Wagner, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01317537     History of Changes
Other Study ID Numbers: HS017234
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: March 17, 2011
Last Verified: March 2011

Keywords provided by Augusta University:
personal health records

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases