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

NCT ID: NCT01905176

Last Updated: 2013-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-05-31

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Predischarge educational intervention

In person education on heart failure topics before discharge

Group Type: EXPERIMENTAL

In person education on heart failure topics before discharge

Intervention Type: OTHER

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

Telephone educational intervention

Telephone support and education post-discharge

Group Type: EXPERIMENTAL

Telephone support and education post-discharge

Intervention Type: 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

Combination

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Usual care (control group)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Athens

OTHER

Sponsor Role: collaborator

Cyprus University of Technology

OTHER

Sponsor Role: lead

Responsible Party

Ekaterini Lambrinou

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ekaterini Lambrinou

Role: STUDY_DIRECTOR

Cyprus University of Technology

Locations

Cyprus University of Technology; Nursing Department

Limassol, Limassol District, Cyprus

Site Status: RECRUITING

Countries

Cyprus

Central Contacts

Ekaterini Lambrinou, PhD

Role: CONTACT

ekaterini.lambrinou@cut.ac.cy

+35799255576

Fotini Kalogirou, MSc

Role: CONTACT

fotini.kalogirou@cut.ac.cy

+35799636583

Facility Contacts

Ekaterini Lambrinou, PhD

Role: primary

ekaterini.lambrinou@cut.ac.cy

+35799255576

Fotini Kalogirou, MSc

Role: backup

fotini.kalogirou@cut.ac.cy

+35799636583

References

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.

Reference Type: DERIVED

PMID: 39873659 (View on PubMed)

Other Identifiers

MEETTinCY

Identifier Type: -

Identifier Source: org_study_id