Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
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|ClinicalTrials.gov Identifier: NCT00439842|
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : April 17, 2015
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 (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure, Congestive||Behavioral: Heart Failure Group Clinic Appointments||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||198 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||HF Group Clinic Appointments: Rehospitalization Prevention|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||November 2014|
Experimental: HF group clinic appointments
HF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner.
Behavioral: Heart Failure Group Clinic Appointments
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
Other Name: HFcareGroup
No Intervention: Standard HF care
Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.
- rehospitalization or death [ Time Frame: 12 months ]
- HF self-management:problem-solving, self-care behaviors [ Time Frame: 6 and 12 months ]
- heart failure knowledge and preparedness for home care [ Time Frame: 6 and 12 months ]
- functional health status, quality of life, satisfaction with health care, health services use [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439842
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Carol Smith, PhD, RN||University of Kansas Medical Center|