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

HF Group Clinic Appointments: Rehospitalization Prevention

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00439842
Enrollment
198
Registered
2007-02-26
Start date
2007-03-31
Completion date
2014-11-30
Last updated
2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

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.

Interventions

BEHAVIORALHeart Failure Group Clinic Appointments

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rehospitalization or death12 months

Secondary

MeasureTime frame
HF self-management:problem-solving, self-care behaviors6 and 12 months
heart failure knowledge and preparedness for home care6 and 12 months
functional health status, quality of life, satisfaction with health care, health services use12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026