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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Heart Failure

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Predischarge educational intervention<br>In person education on heart failure topics before discharge | Other: In person education on heart failure topics before discharge<br>* Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet<br>|
| Experimental: Telephone educational intervention<br>Telephone support and education post-discharge | Other: Telephone support and education post-discharge<br>* Individualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition<br>|
| Experimental: Combination<br>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<br>* 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<br>|
| No Intervention: Usual care (control group)<br>Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart Failure, Randomized Control Trial, Disease management, Self-care, Nursing, Patient education as topic