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

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ClinicalTrials.gov Identifier: NCT01905176
Recruitment Status : Unknown
Verified July 2013 by Ekaterini Lambrinou, Cyprus University of Technology.
Recruitment status was:  Recruiting
First Posted : July 23, 2013
Last Update Posted : July 23, 2013
Sponsor:
Collaborator:
University of Athens
Information provided by (Responsible Party):
Ekaterini Lambrinou, Cyprus University of Technology

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.

Condition or disease Intervention/treatment Phase
Heart Failure 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : April 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Predischarge educational intervention
In person education on heart failure topics before discharge
Other: 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

Experimental: Telephone educational intervention
Telephone support and education post-discharge
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

Experimental: Combination
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
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

No Intervention: Usual care (control group)
Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning



Primary Outcome Measures :
  1. Change from baseline in heart failure related quality of life at 3 months [ Time Frame: 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 :
  1. Change from baseline in heart failure self-care behavior at 3 months [ Time Frame: 3 months ]
    Measuring the difference from baseline to 3 months, in self-care behavior scores by using a heart failure specific instrument

  2. Combined outcome of readmission or death at 3 months post discharge [ Time Frame: 3 months ]
    Number of participants presented with at least one event in terms of rehospitalization and / or death, during the 3 months follow up period

  3. Change in heart failure knowledge from baseline to 3 months [ Time Frame: 3 months ]
    Measuring the difference, from baseline to 3 months, in heart failure knowledge scores by using a heart failure specific instrument

  4. Change from baseline in general health status (functioning) at 3 months [ Time Frame: 3 months ]
    Measuring the change, from baseline to 3 months, in general health status (functioning), by using a non-disease specific instrument



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01905176


Contacts
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Contact: Ekaterini Lambrinou, PhD +35799255576 ekaterini.lambrinou@cut.ac.cy
Contact: Fotini Kalogirou, MSc +35799636583 fotini.kalogirou@cut.ac.cy

Locations
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Cyprus
Cyprus University of Technology; Nursing Department Recruiting
Limassol, Cyprus, 3036
Contact: Ekaterini Lambrinou, PhD    +35799255576    ekaterini.lambrinou@cut.ac.cy   
Contact: Fotini Kalogirou, MSc    +35799636583    fotini.kalogirou@cut.ac.cy   
Sub-Investigator: Andreas Protopapas, MSc         
Sponsors and Collaborators
Cyprus University of Technology
University of Athens
Investigators
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Study Director: Ekaterini Lambrinou Cyprus University of Technology
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Responsible Party: Ekaterini Lambrinou, Assistant Professor, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01905176    
Other Study ID Numbers: MEETTinCY
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: July 23, 2013
Last Verified: July 2013
Keywords provided by Ekaterini Lambrinou, Cyprus University of Technology:
Heart Failure
Randomized Control Trial
Disease management
Self-care
Nursing
Patient education as topic
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases