Nurse-led Educational Intervention on Heart Failure Patients

NCT05480969 | Completed

• 1 other identifier: 28/18-01-2019
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart failure management programmes; Nurse-led educational interventions; Self-care; Health-related quality of life; Caregiver outcomes

Outcome Measures

Primary Outcomes (1)

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

  Baseline, 6 months

Secondary Outcomes (11)

• 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

Study Arms (3)

Intervention group 1

EXPERIMENTAL

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

Intervention group 2

EXPERIMENTAL

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

Control group

NO INTERVENTION

Control patients and caregivers will receive usual care for heart failure.

Interventions

Heart failure educational intervention OTHER

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.

Intervention group 1; Intervention group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

Attikon University Hospital

Chaïdári, Attica, 12461, Greece

Location

Related Publications (1)

• Thodi M, Bistola V, Lambrinou E, Keramida K, Nikolopoulos P, Parissis J, Farmakis D, Filippatos G. A randomized trial of a nurse-led educational intervention in patients with heart failure and their caregivers: impact on caregiver outcomes. Eur J Cardiovasc Nurs. 2023 Oct 19;22(7):709-718. doi: 10.1093/eurjcn/zvac118.

  PMID: 36510826 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Gerasimos Filippatos, Professor

  2nd Department of Cardiology, Attikon University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Registered Nurse

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: April 19, 2019
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)