Clinical trial NCT01905176: Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus
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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: Heart Failure
Randomized Control Trial
Disease management
Self-care
Nursing
Patient education as topic
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
Collaborators: name: University of Athens
First posted: 2013-07-23
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change from baseline in heart failure related quality of life at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in heart failure self-care behavior at 3 months
timeFrame: 3 months
measure: Combined outcome of readmission or death at 3 months post discharge
timeFrame: 3 months
measure: Change in heart failure knowledge from baseline to 3 months
timeFrame: 3 months
measure: Change from baseline in general health status (functioning) at 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Limassol
country: Cyprus
facility: Cyprus University of Technology; Nursing Department
Study officials:
affiliation: Cyprus University of Technology
name: Ekaterini Lambrinou
role: STUDY_DIRECTOR
References: