HypertensionNCT01317537
Using an Electronic Personal Health Record to Empower Patients With Hypertension
A study testing Electronic personal health record in people with Hypertension, run by Augusta University at 1 site in United States.
Trial summary
Project Summary: An electronic personal health record (ePHR) could maximize patient/clinician collaboration and consequently improve patient self-management and related health outcomes. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Electronic personal health record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 445 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jul 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 21
- hypertension
- referral by physician
Who cannot join
- age over 80
- no hypertension
- too ill to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Health Sciences University
Augusta, Georgia, 30912
About this study
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.
- Conditions
- Hypertension
- Being tested
- Electronic personal health record
- Keywords
- personal health records
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic personal health recordOther
| Study group | Role | What they receive |
|---|---|---|
| Received personal health record | Experimental | received personal health record access Receives: Other: Electronic personal health record |
| No personal health record | No intervention | did not receive personal health record |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
2 seated measures taken using manual sphygmometer by trained research associate
Measured: 9 months
Diastolic blood pressure
2 seated measures taken using manual sphygmometer by trained research associate
Measured: 9 months
Secondary outcomes (3)
patient activation
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.
Measured: 9 months
Patient satisfaction with care
Consumer Assessment of Health care--group and clinician survey Patient assessment of chronic care Post study interviews
Measured: 9 months
adherence to guidelines
chart audit of patient care
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startSep 2007
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 445 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Cerner Corporation, The Institute for Patient- and Family-Centered Care
- Investigators
- Peggy J Wagner, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317537
- Sponsor's protocol ID
- HS017234
- Status last verified
- Mar 2011
- First submitted
- 2 Mar 2011
- Last updated
- 17 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22234404
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an Electronic Personal Health Record to Empower Patients With Hypertension
- ClinicalTrials.gov ID
- NCT01317537
- Acronym / sponsor ID
- HS017234
- Conditions
- Hypertension
- Keywords
- personal health records
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Cerner Corporation, The Institute for Patient- and Family-Centered Care
- Study start
- Sep 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 17 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received personal health record | Experimental | Other: Electronic personal health recordreceived personal health record access |
| No personal health record | No intervention | –did not receive personal health record |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 21
- hypertension
- referral by physician
Key exclusion criteria (3 listed)
- age over 80
- no hypertension
- too ill to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic personal health record | Other | Received personal health record |
Primary outcome
Systolic blood pressure
Time frame: 9 months
2 seated measures taken using manual sphygmometer by trained research associate
Diastolic blood pressure
Time frame: 9 months
2 seated measures taken using manual sphygmometer by trained research associate
3 secondary outcomes
patient activation
Time frame: 9 months
Patient satisfaction with care
Time frame: 9 months
adherence to guidelines
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2011.
- Derived from this study: PubMed 22234404Wagner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy J Wagner, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic personal health record in people with Hypertension, run by Augusta University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic blood pressure (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317537, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2011.