Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus

Not Applicable

• Conditions: Heart Failure
• Interventions: Other: In person education on heart failure topics before discharge; Other: Telephone support and education post-discharge; Other: Pre-discharge in person education and post-discharge telephone education and support

• Registration Number: NCT01905176
• Lead Sponsor: Cyprus University of Technology

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 Timeline

• Study Start: 2010-04
• Status Verified: 2013-07
• Study First Submitted: 2013-07-15
• Study First Submitted QC: 2013-07-22
• Last Update Submitted: 2013-07-22
• Study First Posted: 2013-07-23
• Last Update Posted: 2013-07-23
• Primary Completion: 2013-12
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Predischarge educational intervention	In person education on heart failure topics before discharge	In person education on heart failure topics before discharge
Telephone educational intervention	Telephone support and education post-discharge	Telephone support and education post-discharge
Combination	Pre-discharge in person education and post-discharge telephone education and support	Pre-discharge in person education and post-discharge telephone education and support

Primary Outcome Measures

Name	Time	Method
Change from baseline in heart failure related quality of life at 3 months	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 Outcome Measures

Name	Time	Method
Change from baseline in general health status (functioning) at 3 months	3 months	Measuring the change, from baseline to 3 months, in general health status (functioning), by using a non-disease specific instrument
Change from baseline in heart failure self-care behavior at 3 months	3 months	Measuring the difference from baseline to 3 months, in self-care behavior scores by using a heart failure specific instrument
Combined outcome of readmission or death at 3 months post discharge	3 months	Number of participants presented with at least one event in terms of rehospitalization and / or death, during the 3 months follow up period
Change in heart failure knowledge from baseline to 3 months	3 months	Measuring the difference, from baseline to 3 months, in heart failure knowledge scores by using a heart failure specific instrument

Trial Locations

Locations (1)

Cyprus University of Technology; Nursing Department; 🇨🇾 Limassol, Cyprus