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

Not Applicable

Completed

• Conditions: Heart Failure

• Registration Number: NCT07067047
• Lead Sponsor: Leyla Biçen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-01
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-06
• Study First Submitted: 2025-07-04
• Study First Submitted QC: 2025-07-04
• Last Update Submitted: 2025-07-04
• Study First Posted: 2025-07-15
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Congestion Score Improvement	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.

Trial Locations

Locations (1)

İzmir Katip Çelebi University Atatürk Training and Research Hospital; 🇹🇷 İzmir, Turkey