Heart FailureMEETTinCYNCT01905176
Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus
A study testing In person education on heart failure topics before discharge, Telephone support and education post-discharge and Pre-discharge in person education and post-discharge telephone education and support in people with Heart Failure, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- In person education on heart failure topics before discharge, Telephone support and education post-discharge and Pre-discharge in person education and post-discharge telephone education and support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCyprus
- Study dates
- Apr 2010to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitalized adult patients with evidenced HF
- Planned for discharge
- NYHA class I-IV
- Greek speaking
- Able and willing to give informed consent
Who cannot join
- 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
Show all 9Show fewer
- Patients recently undergone surgery (up to 3 months)
- Patients with less than 3 months life expectancy (end-stage)
- Patients with chronic degenerative diseases
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Cyprus University of Technology; Nursing Department
Limassol, Limassol District, 3036
Ekaterini Lambrinou, PhD, +35799255576, ekaterini.lambrinou@cut.ac.cy
Fotini Kalogirou, MSc, +35799636583, fotini.kalogirou@cut.ac.cy
About this study
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.
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- 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
- Keywords
- Heart Failure, Randomized Control Trial, Disease management, Self-care, Nursing, Patient education as topic
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In person education on heart failure topics before dischargeOther
Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet
Telephone support and education post-dischargeOther
Individualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition
Pre-discharge in person education and post-discharge telephone education and supportOther
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
| Study group | Role | What they receive |
|---|---|---|
| Predischarge educational intervention | Experimental | In person education on heart failure topics before discharge Receives: Other: In person education on heart failure topics before discharge |
| Telephone educational intervention | Experimental | Telephone support and education post-discharge Receives: Other: Telephone support and education post-discharge |
| Combination | Experimental | Pre-discharge in person education and post-discharge telephone education and support Receives: Other: Pre-discharge in person education and post-discharge telephone education and support |
| Usual care (control group) | No intervention | Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startApr 2010
- Primary completionDec 2013 (estimated)
- Study completionMay 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Athens
- Responsible party
- Principal investigator, Ekaterini Lambrinou, Cyprus University of Technology
- Investigators
- Ekaterini Lambrinou, Study director, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905176
- Sponsor's protocol ID
- MEETTinCY
- Acronym
- MEETTinCY
- Status last verified
- Jul 2013
- First submitted
- 15 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lambrinou E, Protopapas A, Paikousis L, Middleton N, Papathanassoglou EDE, Sourtzi P, Kaloyirou F. Effectiveness of a multicentre randomized controlled trial with three different nurse-led intervention management programmes for patients with heart failure: the main results of the MEETinCY study. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):290-300. doi: 10.1093/eurjcn/zvae169.
PubMed 39873659
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01905176
- Acronym / sponsor ID
- MEETTinCY / MEETTinCY
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Randomized Control Trial, Disease management, Self-care, Nursing, Patient education as topic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Collaborators
- University of Athens
- Study start
- Apr 2010
- Primary completion
- Dec 2013 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Predischarge educational intervention | Experimental | Other: In person education on heart failure topics before dischargeIn person education on heart failure topics before discharge |
| Telephone educational intervention | Experimental | Other: Telephone support and education post-dischargeTelephone support and education post-discharge |
| Combination | Experimental | Other: Pre-discharge in person education and post-discharge telephone education and supportPre-discharge in person education and post-discharge telephone education and support |
| Usual care (control group) | No intervention | –Patients receive the routine care provided by the hospital which does not involve protocol driven discharge-planning |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Hospitalized adult patients with evidenced HF
- Planned for discharge
- NYHA class I-IV
- Greek speaking
- Able and willing to give informed consent
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In person education on heart failure topics before dischargeIndividualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet | Other | Predischarge educational intervention |
| Telephone support and education post-dischargeIndividualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition | Other | Telephone educational intervention |
| Pre-discharge in person education and post-discharge telephone education and supportPatients 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 | Other | Combination |
Primary outcome
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
4 secondary outcomes
Change from baseline in heart failure self-care behavior at 3 months
Time frame: 3 months
Combined outcome of readmission or death at 3 months post discharge
Time frame: 3 months
Change in heart failure knowledge from baseline to 3 months
Time frame: 3 months
Change from baseline in general health status (functioning) at 3 months
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Derived from this study: PubMed 39873659Lambrinou E, Protopapas A, Paikousis L, Middleton N, Papathanassoglou EDE, Sourtzi P, Kaloyirou F. Effectiveness of a multicentre randomized controlled trial with three different nurse-led intervention management programmes for patients with heart failure: the main results of the MEETinCY study. Eur J Cardiovasc Nurs. 2025 Mar 3;24(2):290-300. doi: 10.1093/eurjcn/zvae169.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterini Lambrinou study director
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In person education on heart failure topics before discharge, Telephone support and education post-discharge and Pre-discharge in person education and post-discharge telephone education and support in people with Heart Failure, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekaterini Lambrinou, PhD (+35799255576, ekaterini.lambrinou@cut.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in heart failure related quality of life at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905176, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2013.