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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure, Congestive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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HF 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.

Group Type EXPERIMENTAL

Heart Failure Group Clinic Appointments

Intervention Type BEHAVIORAL

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

Standard HF care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Heart Failure Group Clinic Appointments

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

Intervention Type BEHAVIORAL

Other Intervention Names

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HFcareGroup

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No