Education and Supportive Partners Improving Self-Care (ENSPIRE)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of the Education and Supportive Partners Improving Self-Care (ENSPIRE) study is
      to compare the effect of a Family Partnership Intervention (FPI) over patient and family
      education and usual heart failure care on physical and mental health outcomes over an 8-month
      period. The study will examine three ways of giving heart failure patients and their family
      members information. This study will help scientists determine if learning these
      communication skills will help people with heart failure to better manage their symptoms and
      improve their health outcomes.
    

Detailed description: 
      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).
    

Intervention name(s): Family Partnership Intervention (FPI); Patient and Family Education; Usual care with educational material
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): HF patient and family receive structured patient and family education sessions plus intervention to improve family communication one month after enrollment.Patient and family member received one individual dyadic education/counseling session after baseline data collection, and two group sessions (2-3 months after baseline) focused on developing family approaches to HF self management.Telephone counseling for the dyad and reinforcing mailed newsletters at 5-6 months after baseline.; HF Patient and one family member receive structured education sessions one month after enrollment.Two sessions, one indivdual with patient-family member dyad after baseline, and one in a group setting between 2-3 months after baseline. The group session was 2 hours in duration. Telephone counseling for the dyad ast 5-6 months, mailed newsletters at Mailed newsletters at 5-6 months.; Usual care with provision of printed educational material, provided once at baseline
Other intervention name(s): Patient Family Education PFE; Usual Care Attention Control
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Heart failure; Family partnership; Patient family education