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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00439842
First received: February 22, 2007
Last updated: January 28, 2013
Last verified: January 2013

February 22, 2007
January 28, 2013
March 2007
May 2013   (final data collection date for primary outcome measure)
rehospitalization or death [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • rehospitalization
  • death
  • functional health status
  • quality of life
  • satisfaction with health care
  • health services use
Complete list of historical versions of study NCT00439842 on ClinicalTrials.gov Archive Site
  • HF self-management:problem-solving, self-care behaviors [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • heart failure knowledge and preparedness for home care [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • functional health status, quality of life, satisfaction with health care, health services use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • problem solving
  • heart failure knowledge and preparedness for home care
Not Provided
Not Provided
 
Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
HF Group Clinic Appointments: Rehospitalization Prevention

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Heart Failure, Congestive
Behavioral: Heart Failure Group Clinic Appointments
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
Other Name: HFcareGroup
  • Experimental: 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.
    Intervention: Behavioral: Heart Failure Group Clinic Appointments
  • No Intervention: Standard HF care
    Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
198
May 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00439842
1RO1 HL085397-05, R01HL085397
Yes
Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center Research Institute
Carol Smith, RN, PhD, FAAN
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Carol Smith, PhD, RN University of Kansas
University of Kansas
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP