NCT00439842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

April 17, 2015

Status Verified

April 1, 2015

Enrollment Period

6.2 years

First QC Date

February 22, 2007

Last Update Submit

April 16, 2015

Conditions

Heart Failure, Congestive

Outcome Measures

Primary Outcomes (1)

  • rehospitalization or death

    12 months

Secondary Outcomes (3)

  • HF self-management:problem-solving, self-care behaviors

    6 and 12 months

  • heart failure knowledge and preparedness for home care

    6 and 12 months

  • functional health status, quality of life, satisfaction with health care, health services use

    12 months

Study Arms (2)

HF group clinic appointments

EXPERIMENTAL

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

Standard HF care

NO INTERVENTION

Standard HF care Standard heart failure education includes cardiologists instructions and hospital discharge information.

Interventions

Heart Failure Group Clinic AppointmentsBEHAVIORAL

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

Also known as: HFcareGroup
HF group clinic appointments

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • speak English/Spanish
  • receiving treatment for congestive heart failure
  • receiving IV diuretics
  • or more HF symptoms
  • be able to participate in follow up visits

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (2)

  • 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.

    PMID: 33978519DERIVED

  • 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.

    PMID: 25236883DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Carol Smith, PhD, RN

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, School of Nursing

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 26, 2007

Study Start

March 1, 2007

Primary Completion

May 1, 2013

Study Completion

November 1, 2014

Last Updated

April 17, 2015

Record last verified: 2015-04

Locations

US(1)