Clinical trial NCT05480969: Nurse-led Educational Intervention on Heart Failure Patients
Official title: The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure management programmes
Nurse-led educational interventions
Self-care
Health-related quality of life
Caregiver outcomes
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: A randomized controlled study to examine the effect of a nurse-led, home/telephone or telephone-only educational intervention on outcomes of heart failure patients and their caregivers.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Men or women aged ≥18 years old.
* Hospitalized for new-onset or decompensated chronic heart failure.

Exclusion Criteria:

* Any severe neuromuscular disease or other disability or mobility problems that preclude performance of six-minute walk test.
* Any severe cognitive dysfunction or psychiatric disease that limit ability to receive education.
* Patients unable to be contacted by phone or other means.

Primary outcomes:
measure: Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6
timeFrame: Baseline, month 6
measure: Time to the first occurrence of a composite of all-cause death or heart failure hospitalization
timeFrame: Time from randomization to first occurrence (up to 6 months)
measure: Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
measure: Change in the EuroQol Health-Related Quality of Life Questionnaire EQ-5D three-level version (EQ-5D-3L) (Greek version) from baseline to month 6
timeFrame: Baseline, month 6
Other outcomes:
Locations:
city: Chaidari
country: Greece
facility: Attikon University Hospital
state: Attica
Study officials:
affiliation: 2nd Department of Cardiology, Attikon University Hospital
name: Gerasimos Filippatos, Professor
role: STUDY_CHAIR
References: