CVD Clinical Trial
Official title:
Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)
The e-Care for Heart Wellness study will look at ways to reduce a person's chances of getting
heart disease. We are asking about 100 Group Health members whose electronic medical record
shows they have uncontrolled high blood pressure to be in the study. Having high blood
pressure increases your future risk of heart attacks and strokes.
There are many things you can do to help keep your heart healthy. Examples include lowering
blood pressure and cholesterol, eating healthier, and being more active. Our goal is to test
whether getting care and supportive emails from a dietician helps people do things like this
to lower their chances of having a heart attack or a stroke.
For some people, this study will involve both research and clinical care. About half the
people in the study will receive care related to heart disease prevention from a dietician.
It's a standard clinical practice for dieticians to help people reduce their risk of heart
attacks and strokes. What's different about this study is using emails from a dietician to
help people take steps to improve their heart health.
Overweight and obese adults are more likely to have hypertension and other risk factors for
cardiovascular disease (CVD). Evidence-based medication and lifestyle strategies exist for
reducing CVD risk, but little is known about the comparative effectiveness and
cost-effectiveness of these strategies and how best to integrate them into routine health
care. We have previously demonstrated that Web-based pharmacist medication management
intervention can cost-effectively improve HTN control (e-BP: Electronic Communication and
Home Blood Pressure Monitoring; R01 HL075263, B. Green, PI). Web-based pharmacy care did not
lead to lifestyle behavior change or weight loss. However patients who lost small amounts of
weight (2 kg or more) were more likely to have controlled BP (p=.008), regardless of their
study group assignment. We propose using Health Information Technology systems (HIT) to
identify asymptomatic patients at moderate risk for CVD and invite them to participate in a
theory-based behavioral intervention that uses the Chronic Care Model as its planning
foundation.
Specific Aims Aim #1: We hypothesize that using electronic databases alone, we can identify
asymptomatic overweight or obese patients, with uncontrolled BP, and at moderate risk for CVD
who might benefit from a behavioral intervention.
Aim #2: We hypothesize that a dietitian-delivered behavioral intervention, that uses a
patient shared EMR and e-communications, can be integrated into routine healthcare and will
result in improved control of modifiable CVD risk. To test this hypothesis we will measure:
Primary outcomes:
1. The proportion of patients who agree to participate and complete the intervention.
2. The change in mean systolic and diastolic BP and weight (kg), and a weight loss of 4 kg
or more, and the change in Framingham risk score.
Secondary outcomes:
1. Patient satisfaction with the intervention, its effects on health related quality of
life (HrQOL) and the cost of delivering the intervention.
Using this information and the results of the e-BP trial we will plan a full scale,
multi-site (2-3 health institutions with comprehensive EMR's and different geographic and
patient populations) multi-factorial randomized trial—to test the comparative effectiveness
of different strategies to improve control of modifiable CVD risk.
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