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

Carol Smith, RN, PhD, FAAN

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Behavioral: Heart Failure Group Clinic Appointments

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00439842

R01HL085397 (U.S. NIH Grant/Contract)

1R01HL085397-05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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198 participants in 2 patient groups

HF group clinic appointments

Experimental group

Description:

HF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner.

Treatment:

Behavioral: Heart Failure Group Clinic Appointments

Standard HF care

No Intervention group

Description:

Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.