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
  Purpose

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
Heart Failure
Behavioral: Family Partnership Intervention (FPI)
Behavioral: Patient and Family Education
Behavioral: Usual care with educational material

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: A Family Partnership Intervention in Heart Failure

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 170
Study Start Date: April 2005
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Usual Care Attention Control
Usual care with provision of supplemental printed educational material on HF self care
Behavioral: Usual care with educational material
Usual care with provision of printed educational material, provided once at baseline
Other Name: Usual Care Attention Control
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.
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
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.
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

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).

  Eligibility

Ages Eligible for Study:   21 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166049

Locations
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
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Sandra B. Dunbar, RN, DSN Emory University School of Nursing
  More Information

No publications provided

Responsible Party: Sandra B. Dunbar, RN, Professor, Emory University, Nell Hodgson Woodruff School of Nursing, Emory University
ClinicalTrials.gov Identifier: NCT00166049     History of Changes
Other Study ID Numbers: IRB00045870, R01NR008800, 1 R01 NR008800-01A1
Study First Received: August 31, 2005
Last Updated: September 6, 2013
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Heart failure
Family partnership
Patient family education

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014