Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF) - Full Text View

Purpose

The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.

It is proposed that the group clinic intervention will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.

Condition	Intervention
Heart Failure, Congestive	Behavioral: Heart Failure Group Clinic Appointments

MedlinePlus related topics:

Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Efficacy Study

Official Title:	HF Group Clinic Appointments: Rehospitalization Prevention

Further study details as provided by University of Kansas:

Primary Outcome Measures:

rehospitalization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
functional health status [ Time Frame: 12 months ] [ Designated as safety issue: No ]
quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
satisfaction with health care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
health services use [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

problem solving [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
heart failure knowledge and preparedness for home care [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	184
Study Start Date:	March 2007
Estimated Study Completion Date:	September 2011
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Heart failure care group	Behavioral: Heart Failure Group Clinic Appointments Heart failure care group
2: No Intervention Standard care group

Detailed Description:

Aim 1 Hypothesis:

The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
Health Services Use will be lower in HFcareGroup than standard care group at 12 months.

Aim 2 Hypothesis:

The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
speak English/Spanish
receiving treatment for congestive heart failure
receiving IV diuretics
2 or more HF symptoms
be able to participate in follow up visits

Exclusion Criteria:

primary right-sided heart failure
HF transient & related to acute MI
HF due to correctable cause
being scheduled for coronary revascularization or any readmission
receiving infusion for HF therapy within 2 weeks
having co-morbidities, life expectancy < 12 months
severe cognitive impairment
D/C to nursing facilities or rehab unit
Currently enrolled in an intervention study or HF management program
being or planning to become pregnant within 12 months
severe cognitive impairment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439842

Contacts


Contact: Andrea Elyachar, MA	913-588-2790	aelyachar@kumc.edu

Locations


United States, Kansas
	University of Kansas Medical Center	Recruiting
	Kansas City, Kansas, United States, 66160
	Contact: Andrea Elyachar, MA 913-588-2790 aelyachar@kumc.edu
	Principal Investigator: Carol Smith, PhD, RN

Sponsors and Collaborators

University of Kansas

National Heart, Lung, and Blood Institute (NHLBI)

Investigators


Principal Investigator:	Carol Smith, PhD, RN	University of Kansas

More Information

Responsible Party:	University of Kansas Medical Center ( Carol Smith )
Study ID Numbers:	1RO1 HL085397-01
First Received:	February 22, 2007
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00439842
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Heart Failure

Heart Diseases

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsors and Collaborators:	University of Kansas National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00439842