NCT07032896

Brief Summary

The aim of this study is to evaluate the effect of nurse-led education on patients' self-efficacy levels, self-care behaviors, medication compliance, and diet compliance in individuals diagnosed with heart failure. This study will be conducted as a randomized controlled experimental study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 24, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

4 months

First QC Date

May 26, 2025

Last Update Submit

June 19, 2025

Conditions

Keywords

Nursingself-careNursing educationNursing care

Outcome Measures

Primary Outcomes (1)

  • European Heart Failure Self-Care Behaviour Scale (EHFScBS)

    The European Heart Failure Self-Care Behavior Scale consists of 12 questions related to life activities to assess the self-care of Heart Failure patients. The scale is a five-point Likert-type scale with a maximum score of 60 and a minimum score of 12. Higher scores on the scale indicate better self-care behavior.The European Heart Failure Self-Care Behavior Scale (EHFScBS) will be utilized to assess changes in patients' self-care behavior levels. This longitudinal approach will allow researchers to observe any improvements or changes in self-care behaviors that may be attributable to the intervention (nurse-led in-hospital education and post-discharge telephone follow-up).

    This assessment will be conducted at two distinct time points: at the beginning of the study (baseline- day 0) and at the end of the 3rd month.

Secondary Outcomes (1)

  • General Self-Efficacy (GSE), The Beliefs About Medication Compliance Scale (BMCS), The Beliefs About Dietary Compliance Scale (BDCS)

    This assessment will be conducted at two distinct time points: at the beginning of the study (baseline- day 0) and at the end of the 3rd month.

Study Arms (2)

intervention group

EXPERIMENTAL

The experimental group will be trained. The training program will be implemented in line with the patient needs determined by the researcher. In order to fill this knowledge gap, existing research findings and evidence-based treatment guidelines have been extensively reviewed. The training program will be based on the guidelines. Before the patient is discharged, the patients who will be included in the intervention group will be interviewed and their verbal and written consents regarding participation in the study and application of the study forms will be obtained. The intervention group will be evaluated at the beginning of the study before training is provided and at the end of the third month when all training sessions are completed.

Behavioral: Nurse-led Patient Education

Control group

NO INTERVENTION

control group routine care

Interventions

The training program will be implemented in line with patient needs determined by the researcher. In order to overcome this lack of information, existing research findings and evidence-based treatment guidelines were extensively reviewed. The training program will be based on the following guidelines. The program will start with a 30-minute individual training session on patients' self-efficacy level, self-care behaviors, medication and diet compliance processes. This training will be carried out in the hospital in accordance with the patient's plan. Discharged intervention group patients will then be interviewed by telephone six times over a period of three months, and two interviews will be scheduled for each of these monthly periods. In order to measure the impact of the intervention, data will be collected twice, before and after the training for the intervention group

intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who have been diagnosed with heart failure in the hospital by a specialist physician,
  • Have stable class I-IV heart failure according to the New York Heart Association (NYHA) classification criteria,
  • Literate,
  • Patients whose clinical condition has stabilized,
  • Diabetes and hypertension under control,
  • Age 18 and over,
  • Have acute and chronic heart failure
  • Individuals who accept the study will be included in the study.

You may not qualify if:

  • Those with a neuromuscular problem,
  • Those with serious cognitive problems and psychiatric illnesses,
  • Those with physical limitations (such as visual or hearing impairment, orthopedic problems),
  • Those under the age of 18,
  • Those who are illiterate,
  • Those who wish to withdraw from the study at any stage of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University Health Services Vocational School, Department of Health Care Services Elderly Care, Antalya, Türkiye

Antalya, Konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The research is a randomized controlled experimental study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor , PhD

Study Record Dates

First Submitted

May 26, 2025

First Posted

June 24, 2025

Study Start

July 15, 2025

Primary Completion

October 31, 2025

Study Completion

October 31, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations