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Sponsors and Collaborators: |
National Institute of Nursing Research (NINR) Emory University |
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Information provided by: | National Institute of Nursing Research (NINR) |
ClinicalTrials.gov Identifier: | NCT00166049 |
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.
Condition | Intervention |
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Heart Failure |
Behavioral: Family Partnership Intervention (FPI) Behavioral: Usual Care Behavioral: Patient and Family Education |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control, Factorial Assignment |
Official Title: | A Family Partnership Intervention in Heart Failure |
Estimated Enrollment: | 262 |
Study Start Date: | April 2005 |
Estimated Study Completion Date: | May 2009 |
Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Behavioral: Usual Care
Patient and family member receive standard care from their providers.
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2: Experimental |
Behavioral: Patient and Family Education
HF Patient and one family member receive structured education sessions one month after enrollment.
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3: Experimental |
Behavioral: Family Partnership Intervention (FPI)
HF patient and family receive structured patient and family education sessions plus intervention to improve family communication one month after enrollment.
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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:
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).
Ages Eligible for Study: | 21 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Emory University Hospital | |
Atlanta, Georgia, United States, 30322 | |
Crawford Long Hospital | |
Atlanta, Georgia, United States, 30308 | |
Grady Hospital | |
Atlanta, Georgia, United States, 30303 | |
Atlanta Veterans Affairs (VA) Medical Center | |
Decatur, Georgia, United States, 30033 |
Principal Investigator: | Sandra B. Dunbar, RN, DSN | Emory University School of Nursing |
Responsible Party: | Emory University, Nell Hodgeson Woodruff School of Nursing ( Sandra B. Dunbar, RN, DSN, Professor ) |
Study ID Numbers: | 1 R01 NR008800-01A1, 420-2003 |
Study First Received: | August 31, 2005 |
Last Updated: | August 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00166049 |
Health Authority: | United States: Federal Government |
Heart failure Family partnership Patient family education |
Heart Failure Heart Diseases |
Cardiovascular Diseases |