Clinical trial NCT00439842: Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)
Official title: HF Group Clinic Appointments: Rehospitalization Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-02-26
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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 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

Primary outcomes:
measure: rehospitalization or death
timeFrame: 12 months
Secondary outcomes:
measure: HF self-management:problem-solving, self-care behaviors
timeFrame: 6 and 12 months
measure: heart failure knowledge and preparedness for home care
timeFrame: 6 and 12 months
measure: functional health status, quality of life, satisfaction with health care, health services use
timeFrame: 12 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Carol Smith, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.