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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00758238
Acronym
myBP
Enrollment
120
Registered
2008-09-25
Start date
2008-09-30
Completion date
2009-09-30
Last updated
2008-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, self-management, e-health

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Interventions

OTHERmyBP 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.

Sponsors

Hamilton Health Sciences Corporation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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 group3 months

Secondary

MeasureTime frame
Changes in blood pressure and antihypertensive medications3 months

Countries

Canada

Contacts

Primary ContactDavid Chan, MD
dchan@mcmaster.ca905-575-9409
Backup ContactTina Karwalajtys, PhD
karwalt@mcmaster.ca905-521-2100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026