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Clinical Trials/NCT01905176
NCT01905176UnknownNot Applicable

The Effectiveness of Multiple Nursing Interventions, for Promoting Heart Failure Self-care, on Patients' Quality of Life and Heart Failure Outcomes: A Randomized Control Trial.

Cyprus University of Technology1 site in 1 country300 target enrollmentStarted: April 1, 2010Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
300
Locations
1
Primary Endpoint
Change from baseline in heart failure related quality of life at 3 months

Study Overview

Brief Summary

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support; they are either provided before discharge, post-discharge through telephone, or both.

Detailed Description

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support. HF patients admitted in the public hospitals of the Cyprus Republic are screened for eligibility. Consented patients who meet the inclusion criteria are recruited before their discharge, and are randomly allocated to one of the four groups of the trial. Patients of the three intervention groups receive educational intervention and support, before discharge or post-discharge through telephone, or both. Patients of the fourth group receive the usual care (control group). The patients' follow up period is 3 months. The main purpose of the study is to determine whether the combination of predischarge education/support and tele-management is more efficient in improving HF outcomes, rather than the in-person and telephonic components alone. Outcome measures include quality of life and HF events (re-admissions and death) and time to HF event.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Factorial
Primary Purpose
Supportive Care
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Hospitalized adult patients with evidenced HF
  • •Planned for discharge
  • •NYHA class I-IV
  • •Greek speaking
  • •Able and willing to give informed consent

Exclusion Criteria

  • •Severe mental illness or severly impaired cognitive function
  • •Patients that are to be transferred to nursing or rehabilitation homes
  • •Patients unable to be contacted via telephone
  • •Patients with active cancer
  • •Patients on dialysis
  • •Patients scheduled for surgery
  • •Patients recently undergone surgery (up to 3 months)
  • •Patients with less than 3 months life expectancy (end-stage)
  • •Patients with chronic degenerative diseases

Arms & Interventions

Predischarge educational intervention

Experimental

In person education on heart failure topics before discharge

Intervention: In person education on heart failure topics before discharge (Other)

Telephone educational intervention

Experimental

Telephone support and education post-discharge

Intervention: Telephone support and education post-discharge (Other)

Combination

Experimental

Pre-discharge in person education and post-discharge telephone education and support

Intervention: Pre-discharge in person education and post-discharge telephone education and support (Other)

Usual care (control group)

No Intervention

Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning

Outcomes

Primary Outcomes

Change from baseline in heart failure related quality of life at 3 months

Time Frame: 3 months

Measuring the difference in quality of life scores from baseline to 3 months, by using a disease specific instrument for estimating quality of life in heart failure patients

Secondary Outcomes

  • Change from baseline in general health status (functioning) at 3 months(3 months)
  • Change from baseline in heart failure self-care behavior at 3 months(3 months)
  • Combined outcome of readmission or death at 3 months post discharge(3 months)
  • Change in heart failure knowledge from baseline to 3 months(3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ekaterini Lambrinou

Assistant Professor

Cyprus University of Technology

Study Sites (1)

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