Education and Supportive Partners Improving Self-Care (ENSPIRE)

Heart failure is a condition where the heart's pumping ability is reduced, causing shortness
of breath, fatigue, fluid-weight gain, and swelling in the abdomen or legs among other
symptoms. HF patients can learn to manage their diet, exercise, and medications to reduce
these symptoms. Research has shown that people who learn communication skills that involve
problem solving and support are often more successful at maintaining lifestyle changes, such
as diet and exercise, than those who do not receive this type of training. Routine heart
failure care varies, but usually includes patient education about medications and a low
sodium diet to prevent fluid buildup and dietary fluid restriction. This study will help
advance the scientific understanding of how to best influence and sustain recommended
lifestyle changes for HF patients.

The study will investigate three ways of giving HF patients and their family members
information. The first method is routine HF care; this serves as the control group. The
second method adds a patient and family HF education protocol to routine HF care, and the
third method adds a Family Partnership Intervention (FPI). The FPI is an experimental
procedure that involves discussion and training in ways to improve communication within
families. The study takes place over the course of a year. Two hundred sixty two people and
their family members will be asked to participate from Emory, Crawford Long, the VA Medical
Center and Grady Healthcare System.

Procedures:

All groups will participate in the following activities:

- Complete questionnaires at start of study, then 4 and 8 months afterward (3 times)

- Keep four appointments lasting 1- 4 hours at the General Clinical Research Center
(GCRC) located at Emory or Grady Hospital

- Collect 24-hour urine specimens, one at the start of the study, then 4 and 8 months
afterward (3 times)

- Keep a 3-day food record, writing down everything you eat and drink, starting two days
before each 24-hour urine collection (3 times)

- Use a medication monitoring system attached to the bottle cap of your heart failure
medications

- Take a six-minute walk test in which you walk for up to six minutes at the start of
study and then 4 and 8 months afterward (3 times)

- Provide blood samples for Brain Natriuretic Peptide (BNP) levels to determine the level
of heart failure present at the start of the study and then 4 and 8 months afterward (3
times)

In addition to the above activities, you will be assigned to one of three groups by a
computer program. There is a one in three chance of being in any given group.

First Method: The first group will receive routine HF care in addition to participating in
the activities listed above.

Second Method: The second group will attend two HF education classes with their family
member and with a registered nurse and dietician in addition to routine HF care and
participating in the activities listed above. An educational HF newsletter will be sent and
subjects will receive two telephone calls by an RN at two weeks and five months after start
of the study (1 time for newsletter and two phone calls).

Third Method: The third group will attend patient and family HF education classes and
support group meetings with their family member in addition to routine HF care and
participating in the activities listed above. An educational HF newsletter with additional
information about building Family Partnerships will be sent and an RN will call at two weeks
and five months after start of the study (1 time for newsletter and two phone calls).

Inclusion Criteria:

- Documented diagnosis of heart failure (New York Heart Association [NYHA] Class II or
III)

- Aged 21-79

- Currently taking angiotensin-converting enzyme (ACE) inhibitor and diuretic
medications

- Recommended to exercise and low sodium diet

- Willing to participate in educational sessions with a family member

- Willing to spend a minimum of 9 hours and a maximum of 15 hours over an 8-month
period

- Willing to travel to either Emory University Hospital or Grady Memorial Hospital
General Clinical Research Center (GCRC) for study activities

Exclusion Criteria:

- NYHA Class I or IV heart failure

- Heart attack within the last 6 months

- Kidney failure

- Significant angina/chest pain

- Inability to read and write English