NCT01317537

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
445

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Sep 2007

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
Last Updated

March 17, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

March 2, 2011

Last Update Submit

March 16, 2011

Conditions

Hypertension

Keywords

personal health records

Outcome Measures

Primary Outcomes (2)

  • Systolic blood pressure

    2 seated measures taken using manual sphygmometer by trained research associate

    9 months

  • Diastolic blood pressure

    2 seated measures taken using manual sphygmometer by trained research associate

    9 months

Secondary Outcomes (3)

  • patient activation

    9 months

  • Patient satisfaction with care

    9 months

  • adherence to guidelines

    9 months

Study Arms (2)

Received personal health record

EXPERIMENTAL

received personal health record access

Other: Electronic personal health record

No personal health record

NO INTERVENTION

did not receive personal health record

Interventions

Electronic personal health recordOTHER
Received personal health record

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 21
  • hypertension
  • referral by physician

You may not qualify if:

  • age over 80
  • no hypertension
  • too ill to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

Location

Related Publications (1)

  • Wagner PJ, Dias J, Howard S, Kintziger KW, Hudson MF, Seol YH, Sodomka P. Personal health records and hypertension control: a randomized trial. J Am Med Inform Assoc. 2012 Jul-Aug;19(4):626-34. doi: 10.1136/amiajnl-2011-000349. Epub 2012 Jan 10.

    PMID: 22234404DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Peggy J Wagner, PhD

    Augusta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 2, 2011

First Posted

March 17, 2011

Study Start

September 1, 2007

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

March 17, 2011

Record last verified: 2011-03

Locations

US(1)