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

NCT00758238 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2008-09-25

No results posted yet for this study

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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

Interventions

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.

Sponsors & Collaborators

  • Hamilton Health Sciences Corporation

    lead OTHER

Principal Investigators

  • Lisa Dolovich, PharmD · McMaster University

  • David Chan, MD · McMaster University

  • Tina Karwalajtys, PhD · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-06-30
Completion
2009-09-30

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00758238 on ClinicalTrials.gov