Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Heart Failure Group Clinic Appointments
Sponsored by
About this trial
This is an interventional prevention trial for Heart Failure, Congestive
Eligibility 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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
HF group clinic appointments
Standard HF care
Arm Description
HF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner.
Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.
Outcomes
Primary Outcome Measures
rehospitalization or death
Secondary Outcome Measures
HF self-management:problem-solving, self-care behaviors
heart failure knowledge and preparedness for home care
functional health status, quality of life, satisfaction with health care, health services use
Full Information
NCT ID
NCT00439842
First Posted
February 22, 2007
Last Updated
April 16, 2015
Sponsor
Carol Smith, RN, PhD, FAAN
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00439842
Brief Title
Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
Official Title
HF Group Clinic Appointments: Rehospitalization Prevention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Carol Smith, RN, PhD, FAAN
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
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.
Health Services Use will be lower in HFcareGroup than standard care group at 12 months.
Aim 2 Hypothesis:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HF group clinic appointments
Arm Type
Experimental
Arm Description
HF group clinic appointments Heart failure multidisciplinary group clinic appointments (Arm 1 - HFcareGroup) includes 6 teaching sessions with patients led by nurse practitioner.
Arm Title
Standard HF care
Arm Type
No Intervention
Arm Description
Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.
Intervention Type
Behavioral
Intervention Name(s)
Heart Failure Group Clinic Appointments
Other Intervention Name(s)
HFcareGroup
Intervention Description
Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)
Primary Outcome Measure Information:
Title
rehospitalization or death
Time Frame
12 months
Secondary Outcome Measure Information:
Title
HF self-management:problem-solving, self-care behaviors
Time Frame
6 and 12 months
Title
heart failure knowledge and preparedness for home care
Time Frame
6 and 12 months
Title
functional health status, quality of life, satisfaction with health care, health services use
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Smith, PhD, RN
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33978519
Citation
Piamjariyakul U, Shapiro AL, Wang K, Zulfikar R, Petitte T, Shafique S, Smith CE. Impact of Sleep Apnea, Daytime Sleepiness, Comorbidities, and Depression on Patients' Heart Failure Health Status. Clin Nurs Res. 2021 Nov;30(8):1222-1230. doi: 10.1177/10547738211015545. Epub 2021 May 12.
Results Reference
derived
PubMed Identifier
25236883
Citation
Smith CE, Piamjariyakul U, Wick JA, Spertus JA, Russell C, Dalton KM, Elyachar A, Vacek JL, Reeder KM, Nazir N, Ellerbeck EF. Multidisciplinary group clinic appointments: the Self-Management and Care of Heart Failure (SMAC-HF) trial. Circ Heart Fail. 2014 Nov;7(6):888-94. doi: 10.1161/CIRCHEARTFAILURE.113.001246. Epub 2014 Sep 18.
Results Reference
derived
Learn more about this trial
Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
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