Skip to main content
OpenTrials
Completed

NCT Number: NCT05480969

Nurse-led Educational Intervention on Heart Failure Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Attikon University Hospital

Chaïdári, Attica, 12461, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

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

    Time frame: Baseline, month 6

  8. 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)

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

    Time frame: Baseline, month 6

  10. Change of the Heart Failure-Caregiver Questionnaire (HF-CQ) (Greek version) from baseline to month 6

    Time frame: Baseline, month 6

  11. 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

    Time frame: Baseline, month 6

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2022
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.