e-Care for Heart Wellness

NCT01077388 | Completed Phase 3 DMC

• 1 other identifier: 2R01HL075263-05
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CVD

Keywords

CVD; uncontrolled HTN

Study Arms (2)

Dietician electronic counseling

EXPERIMENTAL

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

Self Care

NO INTERVENTION

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.

Interventions

Dietician electronic support BEHAVIORAL

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.

Dietician electronic counseling

Eligibility Criteria

• Age: 30 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Group Health Cooperative

Seattle, Washington, 98101, United States

Location

Related Publications (2)

• Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid RJ. e-Care for heart wellness: a feasibility trial to decrease blood pressure and cardiovascular risk. Am J Prev Med. 2014 Apr;46(4):368-77. doi: 10.1016/j.amepre.2013.11.009.

  PMID: 24650839 DERIVED

• Green BB, Anderson ML, Cook AJ, Catz S, Fishman PA, McClure JB, Reid R. Using body mass index data in the electronic health record to calculate cardiovascular risk. Am J Prev Med. 2012 Apr;42(4):342-7. doi: 10.1016/j.amepre.2011.12.009.

  PMID: 22424246 DERIVED

Study Officials

• Beverly Green, MD,MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: August 1, 2012
• Last Updated: October 13, 2017

Record last verified: 2017-10

Locations

US (1)