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

NCT ID: NCT00758238

Last Updated: 2008-09-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2009-09-30

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Conditions

Hypertension

Keywords

hypertension; self-management; e-health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

myBP intervention

participants will receive access to hypertension self-management tools and support via a personal patient electronic health record

Group Type: EXPERIMENTAL

myBP facilitated e-health self-management

Intervention Type: OTHER

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.

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: lead

Responsible Party

McMaster University, Department of Family Medicine

Principal Investigators

Lisa Dolovich, PharmD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

David Chan, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Tina Karwalajtys, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Stonechurch Family Health Centre and McMaster Family Practice

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

David Chan, MD

Role: CONTACT

Phone: 905-575-9409

Email: dchan@mcmaster.ca

Tina Karwalajtys, PhD

Role: CONTACT

Phone: 905-521-2100

Email: karwalt@mcmaster.ca

Related Links

http://myoscar.org/

MyOSCAR home page

Other Identifiers

8-42213

Identifier Type: -

Identifier Source: org_study_id