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

Study Overview
=================
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: 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.

Official Title
-----------------
HF Group Clinic Appointments: Rehospitalization Prevention

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Behavioral: Heart Failure Group Clinic Appointments


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HF group clinic appointments<br>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<br>* Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)<br>* Other names: HFcareGroup;|
| No Intervention: Standard HF care<br>Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rehospitalization or death |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF self-management:problem-solving, self-care behaviors |  | 6 and 12 months | 
| heart failure knowledge and preparedness for home care |  | 6 and 12 months | 
| functional health status, quality of life, satisfaction with health care, health services use |  | 12 months |