Nurse-led Educational Intervention on Heart Failure Patients

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

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Heart failure educational intervention

• Study Type: Interventional
• Enrollment (Actual): 73
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attica
    • Chaidari, Attica, Greece, 12461
      • Attikon University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group 1; Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through a combination of home visits and telephone calls performed at regular time intervals for a total period of 6 months.	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.
Experimental: Intervention group 2; Heart failure educational sessions will be provided by the heart failure-trained nurse to patients and caregivers. These will be delivered through telephone calls performed at regular time intervals for a total period of 6 months.	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.
No Intervention: Control group; Control patients and caregivers will receive usual care for heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in the Clinical Summary Score from baseline to month 6 by Kansas City Cardiomyopathy Questionnaire (KCCQ) Greek version	Baseline, 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in the Self-Care of Heart Failure Index (SCHFI) (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 the Self-rating Depression Scale-SDS (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 exercise capacity (6 minute walking test - 6MWT) 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
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 in the Caregiver Guilt Questionnaire (CGQ) (Greek version) from baseline to month 6	Baseline, month 6
Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) 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

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Study Chair: Gerasimos Filippatos, Professor, 2nd Department of Cardiology, Attikon University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Actual): September 14, 2020
• Study Completion (Actual): September 14, 2020

Study Registration Dates

• First Submitted: July 26, 2022
• First Submitted That Met QC Criteria: July 28, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Health-related quality of life; Self-care; Heart failure management programmes; Nurse-led educational interventions; Caregiver outcomes
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 28/18-01-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No