Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
- Conditions
- Heart Failure, Congestive
- Interventions
- Behavioral: Heart Failure Group Clinic Appointments
- Registration Number
- NCT00439842
- Lead Sponsor
- Carol Smith, RN, PhD, FAAN
- Brief Summary
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.
- Detailed Description
Aim 1 Hypothesis:
1. The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
2. 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.
3. Health Services Use will be lower in HFcareGroup than standard care group at 12 months.
Aim 2 Hypothesis:
1. 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.
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 198
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HF group clinic appointments Heart Failure 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.
- Primary Outcome Measures
Name Time Method rehospitalization or death 12 months
- Secondary Outcome Measures
Name Time Method functional health status, quality of life, satisfaction with health care, health services use 12 months HF self-management:problem-solving, self-care behaviors 6 and 12 months heart failure knowledge and preparedness for home care 6 and 12 months
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States