Education and Supportive Partners Improving Self-Care (ENSPIRE)
A Family Partnership Intervention in Heart Failure
3 other identifiers
interventional
170
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Apr 2005
Longer than P75 for not_applicable heart-failure
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedNovember 11, 2015
September 1, 2013
6.1 years
August 31, 2005
November 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Adherence to dietary sodium and medication taking behavior
4 and 8 months after baseline enrollment.
Physical status: 6-minute walk and brain natriuretic peptide
4 and 8 months after baseline enrollment.
Psychological status: depressive symptoms
4 and 8 months after baseline enrollment.
Health related quality of life
4 and 8 months after baseline enrollment.
Secondary Outcomes (4)
Health resource utilization (HRUQ)
4 and 8 months after baseline enrollment.
Autonomy support (AS)
4 and 8 months after baseline enrollment.
Perceived family criticism
4 and 8 months after baseline enrollment.
Knowledge
4 and 8 months after baseline enrollment.
Study Arms (3)
Usual Care Attention Control
PLACEBO COMPARATORUsual care with provision of supplemental printed educational material on HF self care
Group 2 Patient Family Education PFE
EXPERIMENTALPatient 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.
Group 3 Family Partnership Intervention
EXPERIMENTALPatient 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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- National Institute of Nursing Research (NINR)collaborator
Study Sites (4)
Grady Hospital
Atlanta, Georgia, 30303, United States
Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Atlanta Veterans Affairs (VA) Medical Center
Decatur, Georgia, 30033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sandra B. Dunbar, RN, DSN
Emory University School of Nursing
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Emory University, Nell Hodgson Woodruff School of Nursing
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 14, 2005
Study Start
April 1, 2005
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
November 11, 2015
Record last verified: 2013-09