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Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records (myBP)

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ClinicalTrials.gov Identifier: NCT00758238
Recruitment Status : Unknown
Verified September 2008 by McMaster University.
Recruitment status was:  Not yet recruiting
First Posted : September 25, 2008
Last Update Posted : September 25, 2008
Sponsor:
Information provided by:
McMaster University

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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.

Condition or disease Intervention/treatment
Hypertension Other: myBP facilitated e-health self-management

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evidence-Based Development and Initial Evaluation of a Facilitated Patient Self Management e Health Strategy Intervention for Hypertension
Study Start Date : September 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: myBP intervention
participants will receive access to hypertension self-management tools and support via a personal patient electronic health record
Other: myBP facilitated e-health self-management
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.
No Intervention: usual care
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Changes in blood pressure and antihypertensive medications [ Time Frame: 3 months ]


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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00758238


Contacts
Contact: David Chan, MD 905-575-9409 dchan@mcmaster.ca
Contact: Tina Karwalajtys, PhD 905-521-2100 ext 28501 karwalt@mcmaster.ca

Locations
Canada, Ontario
Stonechurch Family Health Centre and McMaster Family Practice Not yet recruiting
Hamilton, Ontario, Canada
Principal Investigator: David Chan, MD         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Investigators
Principal Investigator: Lisa Dolovich, PharmD McMaster University
Principal Investigator: David Chan, MD McMaster University
Principal Investigator: Tina Karwalajtys, PhD McMaster University

Additional Information:
Responsible Party: Lisa Dolovich, David Chan, Tina Karwalajtys (co-principal investigators), McMaster University, Department of Family Medicine
ClinicalTrials.gov Identifier: NCT00758238     History of Changes
Other Study ID Numbers: 8-42213
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: September 25, 2008
Last Verified: September 2008

Keywords provided by McMaster University:
hypertension
self-management
e-health

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases