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

Primary Purpose

Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
In person education on heart failure topics before discharge
Telephone support and education post-discharge
Pre-discharge in person education and post-discharge telephone education and support
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart Failure, Randomized Control Trial, Disease management, Self-care, Nursing, Patient education as topic

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cyprus University of Technology; Nursing DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Predischarge educational intervention

Telephone educational intervention

Combination

Usual care (control group)

Arm Description

In person education on heart failure topics before discharge

Telephone support and education post-discharge

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
July 15, 2013
Last Updated
July 22, 2013
Sponsor
Cyprus University of Technology
Collaborators
University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT01905176
Brief Title
Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology
Collaborators
University of Athens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, Randomized Control Trial, Disease management, Self-care, Nursing, Patient education as topic

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Predischarge educational intervention
Arm Type
Experimental
Arm Description
In person education on heart failure topics before discharge
Arm Title
Telephone educational intervention
Arm Type
Experimental
Arm Description
Telephone support and education post-discharge
Arm Title
Combination
Arm Type
Experimental
Arm Description
Pre-discharge in person education and post-discharge telephone education and support
Arm Title
Usual care (control group)
Arm Type
No Intervention
Arm Description
Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning
Intervention Type
Other
Intervention Name(s)
In person education on heart failure topics before discharge
Intervention Description
Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet
Intervention Type
Other
Intervention Name(s)
Telephone support and education post-discharge
Intervention Description
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
Intervention Name(s)
Pre-discharge in person education and post-discharge telephone education and support
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline in heart failure related quality of life at 3 months
Description
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
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change from baseline in heart failure self-care behavior at 3 months
Description
Measuring the difference from baseline to 3 months, in self-care behavior scores by using a heart failure specific instrument
Time Frame
3 months
Title
Combined outcome of readmission or death at 3 months post discharge
Description
Number of participants presented with at least one event in terms of rehospitalization and / or death, during the 3 months follow up period
Time Frame
3 months
Title
Change in heart failure knowledge from baseline to 3 months
Description
Measuring the difference, from baseline to 3 months, in heart failure knowledge scores by using a heart failure specific instrument
Time Frame
3 months
Title
Change from baseline in general health status (functioning) at 3 months
Description
Measuring the change, from baseline to 3 months, in general health status (functioning), by using a non-disease specific instrument
Time Frame
3 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ekaterini Lambrinou, PhD
Phone
+35799255576
Email
ekaterini.lambrinou@cut.ac.cy
First Name & Middle Initial & Last Name or Official Title & Degree
Fotini Kalogirou, MSc
Phone
+35799636583
Email
fotini.kalogirou@cut.ac.cy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ekaterini Lambrinou
Organizational Affiliation
Cyprus University of Technology
Official's Role
Study Director
Facility Information:
Facility Name
Cyprus University of Technology; Nursing Department
City
Limassol
ZIP/Postal Code
3036
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ekaterini Lambrinou, PhD
Phone
+35799255576
Email
ekaterini.lambrinou@cut.ac.cy
First Name & Middle Initial & Last Name & Degree
Fotini Kalogirou, MSc
Phone
+35799636583
Email
fotini.kalogirou@cut.ac.cy
First Name & Middle Initial & Last Name & Degree
Andreas Protopapas, MSc

12. IPD Sharing Statement

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

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