Clinical trial NCT00758238: Development and Pilot-Testing of a Patient Self Management Approach for Hypertension Using Personal Electronic Health Records
Official title: Evidence-Based Development and Initial Evaluation of a Facilitated Patient Self Management e Health Strategy Intervention for Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: hypertension
self-management
e-health
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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meta-analytic techniques; with specific attention devoted towards accessing information and effectiveness data from unpublished studies or reports within grey literature and contacting individuals with expertise in chronic disease management in primary care.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


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

Primary outcomes:
measure: 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
timeFrame: 3 months
Secondary outcomes:
measure: Changes in blood pressure and antihypertensive medications
timeFrame: 3 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Stonechurch Family Health Centre and McMaster Family Practice
state: Ontario
Study officials:
affiliation: McMaster University
name: Lisa Dolovich, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: David Chan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Tina Karwalajtys, PhD
role: PRINCIPAL_INVESTIGATOR
References: