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
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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 |
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 |

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

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts 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

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
Contact: Ekaterini Lambrinou, PhD | +35799255576 | ekaterini.lambrinou@cut.ac.cy | |
Contact: Fotini Kalogirou, MSc | +35799636583 | fotini.kalogirou@cut.ac.cy |
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 |
Study Director: | Ekaterini Lambrinou | Cyprus University of Technology |
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 |
Heart Failure Randomized Control Trial Disease management |
Self-care Nursing Patient education as topic |
Heart Failure Heart Diseases Cardiovascular Diseases |