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

Hypertension Clinical Trial

— myBP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00758238
• Other study ID #: 8-42213
• Status: Not yet recruiting
• Phase: N/A
• First received: September 23, 2008
• Last updated: September 23, 2008
• Start date: September 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2008
• Source: McMaster University
• Contact: David Chan, MD
• Phone: 905-575-9409
• Email: dchan[@]mcmaster.ca
• Is FDA regulated: No
• Health authority: Canada: Ministry of Health & Long Term Care, Ontario
• Study type: Interventional

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: September 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Hypertension

Intervention

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.

Locations

Country	Name	City	State
Canada	Stonechurch Family Health Centre and McMaster Family Practice	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in blood pressure and antihypertensive medications		3 months	No

External Links

•   MyOSCAR home page