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

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ClinicalTrials.gov Identifier: NCT00439842
Recruitment Status : Completed
First Posted : February 26, 2007
Last Update Posted : April 17, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Carol Smith, RN, PhD, FAAN, University of Kansas Medical Center

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.


Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Behavioral: Heart Failure Group Clinic Appointments Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: HF Group Clinic Appointments: Rehospitalization Prevention
Study Start Date : March 2007
Actual Primary Completion Date : May 2013
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. rehospitalization or death [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. HF self-management:problem-solving, self-care behaviors [ Time Frame: 6 and 12 months ]
  2. heart failure knowledge and preparedness for home care [ Time Frame: 6 and 12 months ]
  3. functional health status, quality of life, satisfaction with health care, health services use [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439842


Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Carol Smith, RN, PhD, FAAN
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Carol Smith, PhD, RN University of Kansas Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Carol Smith, RN, PhD, FAAN, Professor, School of Nursing, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00439842     History of Changes
Other Study ID Numbers: 1R01HL085397-05 ( U.S. NIH Grant/Contract )
R01HL085397 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2007    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases