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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Cyprus
  • Limassol, Cyprus, 3036
    • Recruiting
    • Cyprus University of Technology; Nursing Department
    • Contact: Ekaterini Lambrinou, PhD; Phone Number: +35799255576; Email: ekaterini.lambrinou@cut.ac.cy
    • Contact: Fotini Kalogirou, MSc; Phone Number: +35799636583; Email: fotini.kalogirou@cut.ac.cy
    • Sub-Investigator: Andreas Protopapas, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Predischarge educational intervention; In person education on heart failure topics before discharge	Other: In person education on heart failure topics before discharge; Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet
Experimental: Telephone educational intervention; Telephone support and education post-discharge	Other: Telephone support and education post-discharge; Individualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition
Experimental: Combination; Pre-discharge in person education and post-discharge telephone education and support	Other: Pre-discharge in person education and post-discharge telephone education and support; Patients receive both interventions of Arm 1 & 2: individualized pre-discharge counseling/education along with telephone follow-up support for three months, following the same line as mentioned in Arms 1 & 2
No Intervention: Usual care (control group); Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in heart failure related quality of life at 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	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cyprus University of Technology
• Collaborators: University of Athens
• Investigators: Study Director: Ekaterini Lambrinou, Cyprus University of Technology

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): May 1, 2014

Study Registration Dates

• First Submitted: July 15, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 23, 2013

Study Record Updates

• Last Update Posted (Estimate): July 23, 2013
• Last Update Submitted That Met QC Criteria: July 22, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Heart Failure; Nursing; Self-care; Disease management; Randomized Control Trial; Patient education as topic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MEETTinCY