Nurse-led Educational Intervention on Heart Failure Patients

Attikon Hospital73 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Heart Failure

Interventions

Heart failure educational interventionOTHER

Educational intervention constitutes of a face-to-face session delivered before hospital discharge and outpatient sessions on regular intervals for a total of 6 months. Outpatient sessions in Intervention group 1 constitute of two home-based sessions on months 1 and 3, combined with weekly telephone calls during month 1 and bi-weekly calls during months 2-6. Outpatient sessions in Intervention group-2 constitute of weekly telephone sessions during month 1 and bi-weekly calls during months 2-6. The pre-discharge session will address self-monitoring and health awareness. Education will be provided by in-person discussion and through printed supporting material. Caregiver education will include understanding heart failure and advice on how to support their patient, manage their own health and well-being and how to get help when needed. During outpatient sessions, repeat education will be done and evaluation of implementation of self-care activities.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Attikon University Hospital

Chaïdári, Attica, Greece

Outcomes

Primary Outcomes

Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version

Time frame: Baseline, 6 months

Secondary Outcomes

Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6

Time frame: Baseline, month 6

Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6

Time frame: Baseline, month 6

Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6

Time frame: Baseline, month 6

Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6

Time frame: Baseline, month 6

Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6

Time frame: Baseline, month 6

Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6

Time frame: Baseline, month 6

Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6

Time frame: Baseline, month 6

Time to the first occurrence of a composite of all-cause death or heart failure hospitalization

Time frame: Time from randomization to first occurrence (up to 6 months)

Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6

Data from ClinicalTrials.gov

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