Heart FailureNCT00166049
Education and Supportive Partners Improving Self-Care (ENSPIRE)
A study testing Family Partnership Intervention (FPI) and Patient and Family Education in people with Heart Failure, run by Emory University at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Family Partnership Intervention (FPI) and Patient and Family Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2005to May 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Grady Hospital
Atlanta, Georgia, 30303
Crawford Long Hospital
Atlanta, Georgia, 30308
Emory University Hospital
Atlanta, Georgia, 30322
Atlanta Veterans Affairs (VA) Medical Center
Decatur, Georgia, 30033
About this study
Official title: 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.
Read the 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).
- Conditions
- Heart Failure
- Being tested
- Family Partnership Intervention (FPI), Patient and Family Education, Usual care with educational material
- Keywords
- Heart failure, Family partnership, Patient family education
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Partnership Intervention (FPI)Behavioural
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.
Patient and Family EducationBehavioural
Also called Patient Family Education PFE
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 educational materialBehavioural
Also called Usual Care Attention Control
Usual care with provision of printed educational material, provided once at baseline
| Study group | Role | What they receive |
|---|---|---|
| Usual Care Attention Control | Placebo comparator | Usual care with provision of supplemental printed educational material on HF self care Receives: Behavioral: Usual care with educational material |
| Group 2 Patient Family Education PFE | Experimental | 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. Receives: Behavioral: Patient and Family Education; Behavioral: Usual care with educational material |
| Group 3 Family Partnership Intervention | Experimental | 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. Receives: Behavioral: Family Partnership Intervention (FPI); Behavioral: Patient and Family Education; Behavioral: Usual care with educational material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to dietary sodium and medication taking behavior
Measured: 4 and 8 months after baseline enrollment.
Physical status: 6-minute walk and brain natriuretic peptide
Measured: 4 and 8 months after baseline enrollment.
Psychological status: depressive symptoms
Measured: 4 and 8 months after baseline enrollment.
Health related quality of life
Measured: 4 and 8 months after baseline enrollment.
Secondary outcomes (4)
Health resource utilization (HRUQ)
Measured: 4 and 8 months after baseline enrollment.
Autonomy support (AS)
Measured: 4 and 8 months after baseline enrollment.
Perceived family criticism
Measured: 4 and 8 months after baseline enrollment.
Knowledge
Measured: 4 and 8 months after baseline enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startApr 2005
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Sandra B. Dunbar, RN, Emory University
- Investigators
- Sandra B. Dunbar, RN, DSN, Principal investigator, Emory University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00166049
- Sponsor's protocol ID
- IRB00045870
- Other IDs
- R01NR008800, 1R01NR008800-01A1
- Status last verified
- Sep 2013
- First submitted
- 31 Aug 2005
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Family Partnership Intervention in Heart Failure
- ClinicalTrials.gov ID
- NCT00166049
- Acronym / sponsor ID
- IRB00045870
- Conditions
- Heart Failure
- Keywords
- Heart failure, Family partnership, Patient family education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- Apr 2005
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual Care Attention Control | Placebo comparator | Behavioral: Usual care with educational materialUsual care with provision of supplemental printed educational material on HF self care |
| Group 2 Patient Family Education PFE | Experimental | Behavioral: Patient and Family Education, Behavioral: Usual care with educational materialPatient 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 | Experimental | Behavioral: Family Partnership Intervention (FPI), Behavioral: Patient and Family Education, Behavioral: Usual care with educational materialPatient 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. |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Group 3 Family Partnership Intervention |
| Patient and Family EducationAlso: Patient Family Education PFEHF 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. | Behavioural | Group 2 Patient Family Education PFE, Group 3 Family Partnership Intervention |
| Usual care with educational materialAlso: Usual Care Attention ControlUsual care with provision of printed educational material, provided once at baseline | Behavioural | Group 2 Patient Family Education PFE, Group 3 Family Partnership Intervention, Usual Care Attention Control |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandra B. Dunbar, RN, DSN principal investigator
Emory University School of Nursing
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family Partnership Intervention (FPI) and Patient and Family Education in people with Heart Failure, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to dietary sodium and medication taking behavior (time frame: 4 and 8 months after baseline enrollment.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2015.