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

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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01905176
Acronym
MEETTinCY
Enrollment
300
Registered
2013-07-23
Start date
2010-04-30
Completion date
2014-05-31
Last updated
2013-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

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

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.

Interventions

OTHERIn 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

OTHERTelephone 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

OTHERPre-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

Sponsors

University of Athens
CollaboratorOTHER
Cyprus University of Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in heart failure related quality of life at 3 months3 monthsMeasuring 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

MeasureTime frameDescription
Change from baseline in heart failure self-care behavior at 3 months3 monthsMeasuring 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 discharge3 monthsNumber 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 months3 monthsMeasuring the difference, from baseline to 3 months, in heart failure knowledge scores by using a heart failure specific instrument
Change from baseline in general health status (functioning) at 3 months3 monthsMeasuring the change, from baseline to 3 months, in general health status (functioning), by using a non-disease specific instrument

Countries

Cyprus

Contacts

Primary ContactEkaterini Lambrinou, PhD
ekaterini.lambrinou@cut.ac.cy+35799255576
Backup ContactFotini Kalogirou, MSc
fotini.kalogirou@cut.ac.cy+35799636583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026