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

NCT ID: NCT07067047

Last Updated: 2025-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-03-31

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Nursing Decision Support System Group

Group Type EXPERIMENTAL

Nursing Decision Support System

Intervention Type 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.

Interventions

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Nursing Decision Support System

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Leyla Biçen

OTHER

Sponsor Role lead

Responsible Party

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Leyla Biçen

PhD Candidate in Public Health Nursing, Ege University, Institute of Health Sciences

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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İzmir Katip Çelebi University Atatürk Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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NotApplicable

Identifier Type: OTHER

Identifier Source: secondary_id

0219

Identifier Type: -

Identifier Source: org_study_id

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