Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records (myBP)
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
myBP facilitated e-health self-management
Sponsored by

About this trial
This is an interventional health services research trial for Hypertension focused on measuring hypertension, self-management, e-health
Eligibility Criteria
Inclusion Criteria:
- Over 40 years of age
- Diagnosed with HTN, or being monitored for diagnosis, with a systolic BP >140 (SBP >130 mmHg if diabetes is diagnosed) at an office visit in the previous 6 months
- Own, borrow or be interested in purchasing a BP measurement device for home monitoring; or visit the clinic for self-assessment using the BpTRUTM (www.bptru.org)or monitor BP with a consistent device at a community pharmacy
- Regular access to email, to receive notices of new messages or prompts/reminders in MyOSCAR
Sites / Locations
- Stonechurch Family Health Centre and McMaster Family Practice
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
myBP intervention
usual care
Arm Description
participants will receive access to hypertension self-management tools and support via a personal patient electronic health record
participants allocated to usual care may still opt to use the personal patient electronic health record, but will not have access to the hypertension self-management tools until after the intervention period. The usual care group will be given a web-link for patient hypertension management resources
Outcomes
Primary Outcome Measures
Change in hypertension knowledge, patient self-efficacy, and patient engagement in self management activities after 3 months, in the intervention group compared to the control group
Secondary Outcome Measures
Changes in blood pressure and antihypertensive medications
Full Information
NCT ID
NCT00758238
First Posted
September 23, 2008
Last Updated
September 23, 2008
Sponsor
Hamilton Health Sciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00758238
Brief Title
Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records
Acronym
myBP
Official Title
Evidence-Based Development and Initial Evaluation of a Facilitated Patient Self Management e Health Strategy Intervention for Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
September 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Hamilton Health Sciences Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The project includes a systematic review to inform refinement of intervention components and a pilot RCT to determine the uptake, feasibility, and potential value of a hypertension self-management strategy using personal health records. The review follows generally acceptable systematic review and/or meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care. Findings of the review will be used to expand/modify an existing intervention 'template' to yield an evidence-based strategy with potential to enhance self-management of hypertension in primary care. The pilot RCT will assess the utility of the multifaceted intervention, delivered in part via a secure patient-controlled personal electronic health record, compared with the usual family practice management, for patients with undiagnosed or uncontrolled elevated blood pressure. Patients who are hypertensive or identified as high risk are expected to benefit from the increased flexibility and autonomy of out-of-physician-office self-monitoring with self-management support. This initial evaluation will focus on the change in hypertension knowledge, patient self-efficacy, and patient engagement in self management activities after 3 months, in the intervention group compared to the control group; the feasibility and acceptability of the intervention to patients and providers; and the processes involved in linking the patient self-management experience back to the patient's health care providers to promote coordination of care. Secondary outcomes include change in blood pressure, number and content of interactions with providers, and changes in management, including antihypertensive medication.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, self-management, e-health
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
myBP intervention
Arm Type
Experimental
Arm Description
participants will receive access to hypertension self-management tools and support via a personal patient electronic health record
Arm Title
usual care
Arm Type
No Intervention
Arm Description
participants allocated to usual care may still opt to use the personal patient electronic health record, but will not have access to the hypertension self-management tools until after the intervention period. The usual care group will be given a web-link for patient hypertension management resources
Intervention Type
Other
Intervention Name(s)
myBP facilitated e-health self-management
Intervention Description
MyOSCAR, a web-based patient-controlled personal health record, provides a mechanism for patients to enter/track health information and can encourage longitudinal patient engagement, better interaction between patients and health care providers, and patient self management. The intervention will provide access via MyOSCAR to a cardiovascular risk profile and BP tracker with sharing to providers enabled. Patients can receive general information about hypertension management; tailored messages related to their modifiable risk factors; and secure messaging with multiple providers. Providers can draw on a 'menu' of links/resources to share with patients. A lifestyle changes planner/checklist and an enhanced medication diary are additional components.
Primary Outcome Measure Information:
Title
Change in hypertension knowledge, patient self-efficacy, and patient engagement in self management activities after 3 months, in the intervention group compared to the control group
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes in blood pressure and antihypertensive medications
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Over 40 years of age
Diagnosed with HTN, or being monitored for diagnosis, with a systolic BP >140 (SBP >130 mmHg if diabetes is diagnosed) at an office visit in the previous 6 months
Own, borrow or be interested in purchasing a BP measurement device for home monitoring; or visit the clinic for self-assessment using the BpTRUTM (www.bptru.org)or monitor BP with a consistent device at a community pharmacy
Regular access to email, to receive notices of new messages or prompts/reminders in MyOSCAR
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Chan, MD
Phone
905-575-9409
Email
dchan@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tina Karwalajtys, PhD
Phone
905-521-2100
Ext
28501
Email
karwalt@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa Dolovich, PharmD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Chan, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tina Karwalajtys, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stonechurch Family Health Centre and McMaster Family Practice
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Chan, MD
12. IPD Sharing Statement
Links:
URL
http://myoscar.org/
Description
MyOSCAR home page
Learn more about this trial
Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records
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