e-Care for Heart Wellness (e-Compare)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Group Health Cooperative
ClinicalTrials.gov Identifier:
NCT01077388
First received: February 25, 2010
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
CVD
Behavioral: Dietician electronic support
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Collaborative Behavioral e-Care to Decrease Cardiovascular Risk (e-Compare)

Further study details as provided by Group Health Cooperative:

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: August 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   30 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All adults age 30-<70 men and women who have received care at GH primary care medical centers in Western Washington and who have been continuously enrolled in GH for at least 2 years.
  • BMI 26 or higher,
  • Uncontrolled HTN (based on the 2 most recent visits), and moderate risk for CVD.

Exclusion Criteria:

  • A history of any type of cardiovascular disease (CVD). Including TIA, stroke, coronary heart disease (CHD), angina, congestive heart failure (CHF), peripheral arterial disease (PAD), ar, CHF, PAD), arrhythmias, cardiomyopathy, and valvular disease.
  • Pre existing diagnosis of diabetes
  • Diagnosis of a serious life threatening or limiting condition
  • Pre existing diagnosis of alcohol or chemical dependency
  • Pregnant or planning on becoming pregnant in the next 6 months. Women randomized to the intervention group who become pregnant during the study will be given the option of continuing the intervention in conjunction with usual pre-natal care provided by GH, but will not be included in the final analysis for the study. Women randomized to the self care group who become pregnant during the study will be given the home monitoring equipment usually given to the control group at the end of the study. They will then be referred for usual care and will also not be included in the final analysis for the study.
  • Unable or unwilling to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077388

Locations
United States, Washington
Group Health Cooperative
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Group Health Cooperative
Investigators
Principal Investigator: Beverly Green, MD,MPH Group Health Cooperative
  More Information

No publications provided by Group Health Cooperative

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Group Health Cooperative
ClinicalTrials.gov Identifier: NCT01077388     History of Changes
Other Study ID Numbers: 2R01HL075263-05
Study First Received: February 25, 2010
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Group Health Cooperative:
CVD
uncontrolled HTN

ClinicalTrials.gov processed this record on October 19, 2014