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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01905176
Date of registration: 15/07/2013
Prospective Registration: No
Primary sponsor: Cyprus University of Technology
Public title: Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus MEETTinCY
Scientific 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.
Date of first enrolment: April 2010
Target sample size: 300
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT01905176
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care  
Phase:  N/A
Countries of recruitment
Cyprus
Contacts
Name:     Ekaterini Lambrinou, PhD
Address: 
Telephone: +35799255576
Email: ekaterini.lambrinou@cut.ac.cy
Affiliation: 
Name:     Ekaterini Lambrinou, PhD
Address: 
Telephone: +35799255576
Email: ekaterini.lambrinou@cut.ac.cy
Affiliation: 
Name:     Ekaterini Lambrinou
Address: 
Telephone:
Email:
Affiliation:  Cyprus University of Technology
Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Heart Failure
Intervention(s)
Other: Telephone support and education post-discharge
Other: Pre-discharge in person education and post-discharge telephone education and support
Other: In person education on heart failure topics before discharge
Primary Outcome(s)
Change from baseline in heart failure related quality of life at 3 months [Time Frame: 3 months]
Secondary Outcome(s)
Change from baseline in heart failure self-care behavior at 3 months [Time Frame: 3 months]
Change from baseline in general health status (functioning) at 3 months [Time Frame: 3 months]
Change in heart failure knowledge from baseline to 3 months [Time Frame: 3 months]
Combined outcome of readmission or death at 3 months post discharge [Time Frame: 3 months]
Secondary ID(s)
MEETTinCY
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University of Athens
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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