The Effect of a Nurse-led Educational Intervention on Self-management and Prognosis of Patients With Heart Failure

Attikon Hospital1 site in 1 country73 target enrollmentApril 19, 2019

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Attikon Hospital
Enrollment: 73
Locations: 1
Primary Endpoint: Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 19, 2019

End Date

September 14, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Attikon Hospital

Responsible Party

Principal Investigator

Maria Thodi

Registered Nurse

Attikon Hospital

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.

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-rating Depression Scale-SDS (Greek version) from baseline to month 6(Baseline, month 6)
Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6(Baseline, month 6)
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(Baseline, month 6)
Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6(Baseline, month 6)
Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6(Baseline, month 6)
Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6(Baseline, month 6)
Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6(Baseline, month 6)
Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6(Baseline, month 6)
Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6(Baseline, month 6)
Time to the first occurrence of a composite of all-cause death or heart failure hospitalization(Time from randomization to first occurrence (up to 6 months))
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6(Baseline, month 6)