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Completed

NCT Number: NCT07067047

The Effect of Nursing Care Decision Support System Designed for Fluid Volume Excess of Patients With Heart Failure on Clinical Outcomes of Patients and Home Self-Care Outcomes

This study aims to evaluate the effects of a nursing care decision support system designed to reduce fluid overload in patients with heart failure. The goal is to examine its impact on clinical outcomes both during hospitalization and after discharge at home. The study focuses on improving nursing interventions and patient follow-up through structured, evidence-based decision-making tools.

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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

İzmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, 35100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed with heart failure (HF)
  • Aged 18 years or older
  • Ejection fraction below 50%
  • Presence of +1 or greater pitting edema in the extremities
  • Voluntary agreement to participate in the study
  • Sufficient cognitive and communicative ability to participate in interviews and complete scales/forms

Exclusion criteria

  • Presence of additional comorbidities other than cardiac risk factors (e.g., dialysis-dependent renal failure, lymphedema, oncology patients, etc.)
  • Presence of severe valvular stenosis
  • History of amputation
  • Classified as morbidly obese
  • Isolated right heart failure
  • Inadequate cooperation or communication skills
  • Terminal stage patients
  • Absence of echocardiographic evaluation
  • BNP level not measured

Criteria for Discontinuation During the Study:

  • Inaccessible by phone
  • Withdrawal of consent
  • Development of poor general condition during follow-up
  • Transferred to intensive care units during follow-up
  • Extended hospitalization due to infection or other secondary causes

Treatment and study plan

Nursing Decision Support System

Behavioral

A behavioral intervention involving a nurse-led decision support system designed to manage fluid volume overload in heart failure patients. The intervention guided nursing care planning, monitoring, and evaluation during hospitalization and through home follow-up visits.

Primary outcomes

  1. Congestion Score Improvement

    Time frame: Baseline to 30 days post-discharge

    Assessment of the reduction in fluid volume overload symptoms based on a standardized congestion scoring system. The score evaluates parameters such as edema, shortness of breath, and weight changes.

Sponsors and collaborators

Lead sponsor

Leyla Biçen

Other

Registry information

Acronym: HF-DSS-Nursing

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 15, 2025
Registry last updated
Jul 15, 2025

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.

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