Blood Pressure Clinical Trial
Official title:
Interactive Web Program and Health Coaching for Prehypertensive Adults
This project will develop and evaluate an interactive blood pressure self-management program
for adults with prehypertension. The program will target blood pressure self-monitoring and
the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary
Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and
alcohol consumption.
The multi-modal program uses a combination of brief motivational health coaching, periodic
engagement emails, and a robust interactive website to motivate people to take charge of
their blood pressure management before they require medication. All program components were
designed to conform to the underlying principles of motivational interviewing. Key program
components include the use of email and Web-based social networking, personal stories, and a
brief motivational coaching session to engage participants and encourage intrinsically
motivated behavior changes. Self-assessment and tracking tools are combined with educational
content to help participants align their daily lifestyle choices with their personal goals.
The Phase I prototype program promoted moderate physical activity and eating fruits and
vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation
showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation
behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in
physical activity. Participants gave the online program high ratings on satisfaction and
usability, and reported improvements in confidence, readiness, clarity, change strategies,
and interest in visiting the Website as a result of the coaching session.
The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)
with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month
follow-up period. The Phase II trial is expected to show reductions in blood pressure and
improvements in JNC-recommended health behaviors. These changes in the outcome measures are
expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral
intention, motivation, and patient activation.
Approximately a third (31%) of adult Americans are prehypertensive (SBP 120-139 and/or DBP
80-89). Health care providers struggle to provide effective support for
blood-pressure-lowering behavior changes, while patients continue to progress to full
hypertension and the use of antihypertensive medications. Insurers and providers with access
to electronic medical records, claims, and other medical data are in a unique position to
identify prehypertensive adults and target them with a blood pressure self-management
program. Preventing or delaying hypertension should reduce mid-term costs of
antihypertensive medications and, more importantly, long-term costs of care for heart
disease and stroke.
This project will develop and evaluate an interactive blood pressure self-management program
for adults with prehypertension. The program will target blood pressure self-monitoring and
the five proven lifestyle modifications recommended by JNC-7: weight reduction, the Dietary
Approaches to Stop Hypertension (DASH) diet, sodium reduction, physical activity, and
alcohol consumption.
The multi-modal program uses a combination of brief motivational health coaching, periodic
engagement emails, and a robust interactive website to motivate people to take charge of
their blood pressure management before they require medication. All program components were
designed to conform to the underlying principles of motivational interviewing. Key program
components include the use of email and Web-based social networking, personal stories, and a
brief motivational coaching session to engage participants and encourage intrinsically
motivated behavior changes. Self-assessment and tracking tools are combined with educational
content to help participants align their daily lifestyle choices with their personal goals.
The Phase I prototype program promoted moderate physical activity and eating fruits and
vegetables as part of the DASH diet. Results from the within-group (n = 39) evaluation
showed moderate-to-large effect sizes for pre-to-post change in motivation, preparation
behavior, self-efficacy, attitudes, and knowledge, and a small significant increase in
physical activity. Participants gave the online program high ratings on satisfaction and
usability, and reported improvements in confidence, readiness, clarity, change strategies,
and interest in visiting the Website as a result of the coaching session.
The fully developed Phase II product will be evaluated in a large randomized trial (N = 450)
with a 3-month intensive intervention, a 3-month maintenance intervention, and a 3-month
follow-up period. The Phase II trial is expected to show reductions in blood pressure and
improvements in JNC-recommended health behaviors. These changes in the outcome measures are
expected to be mediated by changes in knowledge, attitudes, self-efficacy, behavioral
intention, motivation, and patient activation.
The Phase II product will be marketed to large, integrated health benefits providers with
both insurance and wellness products, like the investigators Phase II evaluation partner
Aetna, and to integrated health service delivery systems, like the investigators Phase I and
II evaluation partner, Providence Health.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Open Label
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