An interventional study of Family Partnership Intervention (FPI) and Patient and Family Education in Heart Failure, sponsored by Emory University. Completed at 4 sites in United States. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2015-11-11.
Sponsored by Emory University · Not applicable and Interventional
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.
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).
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 170 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Emory University is the lead sponsor of 1,386 studies on the registry; 236 are open to participants now.
Of its 229 completed or terminated interventional studies of FDA-regulated products, 174 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Usual care with provision of supplemental printed educational material on HF self care
Behavioral: Usual care with educational material
Patient Family Education PFE Heart Failure Patients and family member dyads were provided with an educational and counseling session, and attended a 2 hour patient-family education session on heart failure self management with emphasis on dietary sodium and medication taking behaviors.
Behavioral: Patient and Family Education · Behavioral: Usual care with educational material
Patient and family member received one individual dyadic education/counseling session, and two group sessions focused on developing family approaches to HF self management. the emphasis of the two group sessions was on developing autonomy supportive approaches to family support.
Behavioral: Family Partnership Intervention (FPI) · Behavioral: Patient and Family Education · Behavioral: Usual care with educational material
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.
Also known as: Patient Family Education PFE
Usual care with provision of printed educational material, provided once at baseline
Also known as: Usual Care Attention Control
Adherence to dietary sodium and medication taking behavior
Time frame: 4 and 8 months after baseline enrollment.
Physical status: 6-minute walk and brain natriuretic peptide
Time frame: 4 and 8 months after baseline enrollment.
Psychological status: depressive symptoms
Time frame: 4 and 8 months after baseline enrollment.
Health related quality of life
Time frame: 4 and 8 months after baseline enrollment.
Health resource utilization (HRUQ)
Time frame: 4 and 8 months after baseline enrollment.
Autonomy support (AS)
Time frame: 4 and 8 months after baseline enrollment.
Perceived family criticism
Time frame: 4 and 8 months after baseline enrollment.
Knowledge
Time frame: 4 and 8 months after baseline enrollment.
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
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