Nurse-led Educational Intervention on Heart Failure Patients

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480969
• Other study ID #: 28/18-01-2019
• Status: Completed
• Phase: N/A
• Start date: April 19, 2019
• Est. completion date: September 14, 2020

Study information

• Verified date: July 2022
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Heart failure educational intervention
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.

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Chaidari	Attica

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version		Baseline, 6 months
Secondary	Change in the Self-Care of Heart Failure Index (SCHFI) (Greek version) from baseline to month 6		Baseline, month 6
Secondary	Change in the European Heart Failure Self-care Behavior Scale (EHFScBS-9) (Greek version) from baseline to month 6		Baseline, month 6
Secondary	Change in the Dutch Heart Failure Knowledge Scale Greek version from baseline to month 6		Baseline, month 6
Secondary	Change in the Self-rating Depression Scale-SDS (Greek version) from baseline to month 6		Baseline, month 6
Secondary	Change in the Mini Mental State Examination (MMSE) (Greek version) from baseline to month 6		Baseline, month 6
Secondary	Change in exercise capacity (6 minute walking test - 6MWT) from baseline to month 6		Baseline, month 6
Secondary	Change in plasma levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) from baseline to month 6		Baseline, month 6
Secondary	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)
Secondary	Change in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6		Baseline, month 6
Secondary	Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6		Baseline, month 6
Secondary	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