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

NCT01905176 | Unknown

• 1 other identifier: MEETTinCY
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; Randomized Control Trial; Disease management; Self-care; Nursing; Patient education as topic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Change from baseline in general health status (functioning) at 3 months

  3 months

Study Arms (4)

Predischarge educational intervention

EXPERIMENTAL

In person education on heart failure topics before discharge

Other: In person education on heart failure topics before discharge

Telephone educational intervention

EXPERIMENTAL

Telephone support and education post-discharge

Other: Telephone support and education post-discharge

Combination

EXPERIMENTAL

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

Usual care (control group)

NO INTERVENTION

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

Interventions

In person education on heart failure topics before discharge OTHER

Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet

Predischarge educational intervention

Telephone support and education post-discharge OTHER

Individualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition

Telephone educational intervention

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

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

Combination

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead
• University of Athens: collaborator

Study Sites (1)

Cyprus University of Technology; Nursing Department

Limassol, Limassol District, 3036, Cyprus

RECRUITING

Related Publications (1)

• Lambrinou E, Protopapas A, Paikousis L, Middleton N, Papathanassoglou EDE, Sourtzi P, Kaloyirou F. Effectiveness of a multicentre randomized controlled trial with three different nurse-led intervention management programmes for patients with heart failure: the main results of the MEETinCY study. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):290-300. doi: 10.1093/eurjcn/zvae169.

  PMID: 39873659 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ekaterini Lambrinou

  Cyprus University of Technology

  STUDY DIRECTOR

Central Study Contacts

Ekaterini Lambrinou, PhD

CONTACT

+35799255576; ekaterini.lambrinou@cut.ac.cy

Fotini Kalogirou, MSc

CONTACT

+35799636583; fotini.kalogirou@cut.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 23, 2013
• Study Start: April 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: May 1, 2014
• Last Updated: July 23, 2013

Record last verified: 2013-07

Locations

CY (1)