e-Care for Heart Wellness (e-Compare)
|ClinicalTrials.gov Identifier: NCT01077388|
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : October 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|CVD||Behavioral: Dietician electronic support||Phase 3|
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:
- The proportion of patients who agree to participate and complete the intervention.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||August 2012|
Experimental: Dietician electronic counseling
This arm will receive care and supportive emails and phone calls from a study dietician for about 6 months. We will also provide a blood pressure monitor, a pedometer, and a scale with instructions for using them at home.
Behavioral: Dietician electronic support
Dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, will be integrated into routine healthcare and will result in improved control of modifiable CVD risk.
No Intervention: Self Care
This arm will continue to get care as usual from their regular doctor. They will also get a blood pressure monitor and a scale at the end of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01077388
|United States, Washington|
|Group Health Cooperative|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Beverly Green, MD,MPH||Kaiser Permanente|