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

Heart Failure Clinical Trial

— MEETTinCY  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01905176
• Other study ID #: MEETTinCY
• Status: Recruiting
• Phase: N/A
• First received: July 15, 2013
• Last updated: July 22, 2013
• Start date: April 2010
• Est. completion date: May 2014

Study information

• Verified date: July 2013
• Source: Cyprus University of Technology
• Contact: Ekaterini Lambrinou, PhD
• Phone: +35799255576
• Email: ekaterini.lambrinou[@]cut.ac.cy
• Is FDA regulated: No
• Health authority: Cyprus: Cyprus National Bioethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Heart Failure

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Cyprus	Cyprus University of Technology; Nursing Department	Limassol

Sponsors (2)

Lead Sponsor	Collaborator
Cyprus University of Technology	University of Athens

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No