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

Heart Failure, Congestive Clinical Trial

Official title:

HF Group Clinic Appointments: Rehospitalization Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00439842
• Other study ID #: 1RO1 HL085397-05
• Secondary ID: R01HL085397
• Status: Completed
• Phase: N/A
• First received: February 22, 2007
• Last updated: April 16, 2015
• Start date: March 2007
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: November 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Behavioral:
• Heart Failure Group Clinic Appointments
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Carol Smith, RN, PhD, FAAN	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rehospitalization or death		12 months	No
Secondary	HF self-management:problem-solving, self-care behaviors		6 and 12 months	No
Secondary	heart failure knowledge and preparedness for home care		6 and 12 months	No
Secondary	functional health status, quality of life, satisfaction with health care, health services use		12 months	No