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

Evidence-Based Development and Initial Evaluation of a Facilitated Patient Self Management e Health Strategy Intervention for Hypertension

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Study Overview

• Status: Unknown
• Conditions: Hypertension
• Intervention / Treatment: Other: myBP facilitated e-health self-management

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Chan, MD; Phone Number: 905-575-9409; Email: dchan@mcmaster.ca
• Study Contact Backup: Name: Tina Karwalajtys, PhD; Phone Number: 28501 905-521-2100; Email: karwalt@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Stonechurch Family Health Centre and McMaster Family Practice
      • Principal Investigator: David Chan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in blood pressure and antihypertensive medications	3 months

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• MyOSCAR home page

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Anticipated): June 1, 2009
• Study Completion (Anticipated): September 1, 2009

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (Estimate): September 25, 2008

Study Record Updates

• Last Update Posted (Estimate): September 25, 2008
• Last Update Submitted That Met QC Criteria: September 23, 2008
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Keywords: self-management; hypertension; e-health
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 8-42213