Education and Supportive Partners Improving Self-Care (ENSPIRE)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Sandra B. Dunbar, RN, Emory University
ClinicalTrials.gov Identifier:
NCT00166049
First received: August 31, 2005
Last updated: September 6, 2013
Last verified: September 2013

August 31, 2005
September 6, 2013
April 2005
May 2011   (final data collection date for primary outcome measure)
  • Adherence to dietary sodium and medication taking behavior [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Physical status: 6-minute walk and brain natriuretic peptide [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Psychological status: depressive symptoms [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Health related quality of life [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Adherence to dietary sodium and medication taking behavior
  • Physical Status: 6 minute walk and brain natriuretic peptide
  • Psychological status: depressive symptoms
  • Health related quality of life
Complete list of historical versions of study NCT00166049 on ClinicalTrials.gov Archive Site
  • Health resource utilization (HRUQ) [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Autonomy support (AS) [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Perceived family criticism [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Knowledge [ Time Frame: 4 and 8 months after baseline enrollment. ] [ Designated as safety issue: No ]
  • Health resource utilization (HRUQ)
  • Autonomy support (AS)
  • Perceived family criticism
  • Knowledge
Not Provided
Not Provided
 
Education and Supportive Partners Improving Self-Care (ENSPIRE)
A Family Partnership Intervention in Heart Failure

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:

  • 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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Heart Failure
  • 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.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.
    Other Name: Family Partnership Intervention (FPI)
  • Behavioral: Patient and Family Education
    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.
    Other Name: Patient Family Education PFE
  • Behavioral: Usual care with educational material
    Usual care with provision of printed educational material, provided once at baseline
    Other Name: Usual Care Attention Control
  • Placebo Comparator: Usual Care Attention Control
    Usual care with provision of supplemental printed educational material on HF self care
    Intervention: Behavioral: Usual care with educational material
  • Experimental: Group 2 Patient Family Education PFE
    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.
    Interventions:
    • Behavioral: Patient and Family Education
    • Behavioral: Usual care with educational material
  • Experimental: Group 3 Family Partnership Intervention
    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.
    Interventions:
    • Behavioral: Family Partnership Intervention (FPI)
    • Behavioral: Patient and Family Education
    • Behavioral: Usual care with educational material
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
21 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166049
IRB00045870, R01NR008800, 1 R01 NR008800-01A1
Yes
Sandra B. Dunbar, RN, Emory University
Emory University
National Institute of Nursing Research (NINR)
Principal Investigator: Sandra B. Dunbar, RN, DSN Emory University School of Nursing
Emory University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP