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

NCT07067047 | Completed

• 2 other identifiers: 0219NotApplicable
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Congestion Score Improvement

  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.

  Baseline to 30 days post-discharge

Study Arms (1)

Nursing Decision Support System Group

EXPERIMENTAL

Behavioral: Nursing Decision Support System

Interventions

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.

Nursing Decision Support System Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Leyla Biçen: lead

Study Sites (1)

İzmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate in Public Health Nursing, Ege University, Institute of Health Sciences

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 15, 2025
• Study Start: September 1, 2024
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: July 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)