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

NCT00758238 | Unknown

• 1 other identifier: 8-42213
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Outcome Measures

Primary Outcomes (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

  3 months

Secondary Outcomes (1)

• Changes in blood pressure and antihypertensive medications

  3 months

Study Arms (2)

myBP intervention

EXPERIMENTAL

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

usual care

NO INTERVENTION

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

Interventions

myBP facilitated e-health self-management 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.

myBP intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Hamilton Health Sciences Corporation: lead

Study Sites (1)

Stonechurch Family Health Centre and McMaster Family Practice

Hamilton, Ontario, Canada

Location

Related Links

• MyOSCAR home page

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lisa Dolovich, PharmD

  McMaster University

  PRINCIPAL INVESTIGATOR

• David Chan, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Tina Karwalajtys, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Chan, MD

CONTACT

905-575-9409; dchan@mcmaster.ca

Tina Karwalajtys, PhD

CONTACT

905-521-2100; karwalt@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: September 1, 2009
• Last Updated: September 25, 2008

Record last verified: 2008-09

Locations

CA (1)