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Clinical Trials/NCT00439842
NCT00439842
Completed
N/A

HF Group Clinic Appointments: Rehospitalization Prevention

Carol Smith, RN, PhD, FAAN1 site in 1 country198 target enrollmentMarch 2007

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure, Congestive
Sponsor
Carol Smith, RN, PhD, FAAN
Enrollment
198
Locations
1
Primary Endpoint
rehospitalization or death
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
November 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Carol Smith, RN, PhD, FAAN
Responsible Party
Sponsor Investigator
Principal Investigator

Carol Smith, RN, PhD, FAAN

Professor, School of Nursing

University of Kansas Medical Center

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

Outcomes

Primary Outcomes

rehospitalization or death

Time Frame: 12 months

Secondary Outcomes

  • functional health status, quality of life, satisfaction with health care, health services use(12 months)
  • HF self-management:problem-solving, self-care behaviors(6 and 12 months)
  • heart failure knowledge and preparedness for home care(6 and 12 months)

Study Sites (1)

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