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: April 9, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Heart Failure, Congestive
Behavioral: Heart Failure Group Clinic Appointments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: HF Group Clinic Appointments: Rehospitalization Prevention

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • rehospitalization or death [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 198
Study Start Date: March 2007
Estimated Study Completion Date: June 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Heart Failure Group Clinic Appointments
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
Other Name: HFcareGroup
No Intervention: Standard HF care
Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439842

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Smith, RN, PhD, FAAN
Investigators
Principal Investigator: Carol Smith, PhD, RN University of Kansas
  More Information

No publications provided

Responsible Party: Carol Smith, RN, PhD, FAAN, Professor, School of Nursing, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00439842     History of Changes
Other Study ID Numbers: 1RO1 HL085397-05, R01HL085397
Study First Received: February 22, 2007
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014