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Helping Hearts Research Study

Principal Investigator: Donald T. Bishop, MD
Project Leader: Julie Fieldsend, RN
Research Director: David Kuper, RPh, MS
Target Condition: Case Management of Congestive Heart Failure

What is Congestive Heart Failure?

Congestive Heart Failure (CHF) simply means that the heart is weak and not pumping as well as it should. When the heart is not pumping like it should and therefore not getting enough oxygen and nutrients, it becomes more difficult to do the things a person used to do. This might make a person experience some of the following signs or symptoms:

  • Tiredness or weakness
  • Shortness of breath with any activity
  • Increased coughing or wheezing
  • Light-headedness
  • Trouble laying flat at night
  • Hands, feet, ankles or lower legs swelling

Congestive heart failure will never go away. The good news is that there are many things a person can do to prevent further damage and control some of the signs and symptoms.

The Congestive Heart Failure Study

Heart failure is one of the major public health problems facing the United States today. It is the nation's most rapidly growing cardiovascular disorder and the prevalence of this disorder is estimated to increase substantially in the next decade. Patients who would have died of a heart attack (myocardial infarction) or stroke years ago are now living longer and avoiding these events, but can go on to develop heart failure months or years later. As congestive heart failure (CHF) is a significant problem in the elderly, healthcare costs for this disease alone will rise sharply if better preventative and medical management treatment strategies are not used.

This study is designed to help patients monitor and manage their heart disease. A team of medical experts that may include, but not limited to, physicians, registered nurses, pharmacists, dieticians, cardiac specialists, home health specialists, psychotherapists, and social services workers will be used. Registered nurses will serve as the care coordinators for the study. This trial will have 700 patients enrolled until May 2008.

This study is sponsored by Avera Research Institute and the Center for Medicare and Medicaid Services (CMS), formerly Health Care Financing Administration (HCFA).

Purpose of the Study

The purpose of the study is to test whether a new type of service called "coordinated care management" will help Medicare patients with congestive heart failure to have better coordination of their medical treatment, fewer hospital stays, and better quality of life. Coordinated Care services will include assessment, care planning, patient education, monitoring of symptoms, and increasing communication among multiple healthcare providers.

What will I have to do if I enroll in this study?

This study is entirely voluntary. You are free to choose if you will take part in this study. If you choose not to take part in this study, you will receive your usual medical care as before.

If you choose to enroll in the study, the following will occur:

  • You will be given a consent form and asked to sign the form agreeing to participate in the research study.
  • You will then be randomized (like flipping a coin) into one of two groups. One group--the study group--will receive the coordinated care services and the other group--the control group--will receive care as usual.
  • You will be expected to be in the study from 2 to 4 years.
  • You will continue to see your primary doctor for your medical care.

If you are assigned to the study group, in addition to receiving ongoing care from your doctor, you will also receive the following:

  • A registered nurse will be assigned to you and will complete an initial assessment. The nurse will work with you to develop a plan of care specific to you and your needs.
  • A home monitoring device will be set up in your home at no cost to you. This device will monitor your weight, blood pressure, pulse and oxygen levels in your blood. This information will be sent over the phone line to your care coordinator.
  • You will receive up-to-date information about congestive heart failure and any other diseases you may have.

While taking part in this study, you will not receive any experimental drugs, tests, or treatments.

What can you expect from us?

You can expect and be provided with a program of care specifically designed for you and your needs. There will be a team of healthcare workers (i.e. pharmacist, dietician, exercise specialist, social worker, etc.) available as resources to provide help to you based on your specific needs.

Your contribution to research

As a participant in this research study, you will be helping Avera McKennan and the Medicare program learn more about congestive heart failure and what works best for you and others who have this disease. Your participation is vital for a successful study. We are sure that by working together, we will provide you with the best possible individual care and obtain accurate results for the study.

Frequently Asked Questions

Q. How long will I participate in the study?
A. The study will last 2 years. You may continue in the study the entire time (for 2 years), unless you choose not to continue in the study.

Q. Do I continue to see my own doctor?
A. Yes, you continue to see your own doctor the entire time you are enrolled in the study.

Q. What are the risks?
A.  If you are assigned to the study group, you will have a monitoring device placed in your home. The home monitoring device is operated by electricity and would have risks similar to other electrical appliances. Also, if you are part of the study group, at the end of the study, you will no longer have access to the care coordinator (registered nurse).

Q. What are the benefits?
A. You might feel better after entering the study and your condition may improve. However, we cannot guarantee that you will have medical benefits from taking part in this study. Others may benefit in the future from the information we obtain while you are in the study.

Q. What happens if I am hospitalized during the study?
A. You will receive your regular care if you are hospitalized and continue in either the control group or study group after your hospitalization.

Q. What happens if I want to quit after I start the study?
A. The study is entirely voluntary.  You may choose to stop the study at any time. We ask that you let your doctor and/or the care coordinator know.

Q. Do I have to pay for the home monitoring device and/or drug compliance device(s)?
A. If you are enrolled in the study group, the home monitoring device and/or drug compliance will be set up at no cost to you and you can use it during the entire study. Because these home monitoring devices are part of this study, if you choose not to continue in the study or at the end of the study, the device(s) would need to be returned.

Q. Will I know which treatment group I am assigned to?
A. You will know which treatment group you will be enrolled in. If you are in the control group, you will continue your medical treatment with your doctor as your currently are. If you are enrolled in the study group, a registered nurse will be assigned to you. You will continue to see your doctor but the nurse will work with both you and your doctor to manage your care. You will also have use of a home monitoring device and/or drug compliance device during the time you are enrolled in this study.

Q. What happens if I move during the study?
A. If you move within our tri-state area region (Minnesota, Iowa, South Dakota) while you are enrolled in the study, you may continue in the study. You will need to let your doctor and also your care coordinator know if you are in the study group.

If you are interested in taking part in this research study, please contact the Avera Research Institute toll-free at 1-888-531-1684 or call Mike Janke at (605) 322-6575.

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