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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Cyprus University of Technology
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Change from baseline in heart failure related quality of life at 3 months
- Last Updated
- 12 years ago
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.
Investigators
Ekaterini Lambrinou
Assistant Professor
Cyprus University of Technology
Eligibility Criteria
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
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)