Heart FailureHF-DSS-NursingNCT07067047
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
A study testing Nursing Decision Support System in people with Heart Failure, run by Leyla Biçen at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Nursing Decision Support System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İzmir Katip Çelebi University Atatürk Training and Research Hospital
Izmir, 35100
About this study
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
- Being tested
- Nursing Decision Support System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing Decision Support SystemBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Nursing Decision Support System Group | Experimental | Not described Receives: Behavioral: Nursing Decision Support System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 30 days post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start1 Sep 2024
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leyla Biçen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leyla Biçen, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067047
- Sponsor's protocol ID
- 0219
- Other IDs
- NotApplicable
- Acronym
- HF-DSS-Nursing
- Status last verified
- Jun 2025
- First submitted
- 4 Jul 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07067047
- Acronym / sponsor ID
- HF-DSS-Nursing / 0219
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Leyla BiçenUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nursing Decision Support System Group | Experimental | Behavioral: Nursing Decision Support System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nursing Decision Support SystemA 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. | Behavioural | Nursing Decision Support System Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
- Individual participant dataSharing planned: No
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HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
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Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
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Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing Decision Support System in people with Heart Failure, run by Leyla Biçen at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congestion Score Improvement (time frame: Baseline to 30 days post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2025.