Heart FailureNCT07032896
The Effect of Nurse-Led Education in Heart Failure Patients
A study testing Nurse-led Patient Education in people with Heart Failure, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. 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?
- Nurse-led Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2025to 31 Dec 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
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Akdeniz University Health Services Vocational School, Department of Health Care Services Elderly Care, Antalya, Türkiye
Antalya, Konyaaltı, 07070
About this study
Official title: 'The Effect of Nurse-Led Education on Patients' Self-Care Behaviour, Self-Efficacy Level, Medication and Diet Compliance in Individuals With Heart Failure'.
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.
Read the detailed description
This study, to be conducted at the Akdeniz University Hospital Cardiology Department and Outpatient Clinic, aims to evaluate the impact of nurse-led education on heart failure patients' self-efficacy, self-care behaviors, and adherence to medication and diet.
Study Population The study sample will comprise heart failure patients aged 18 years and older who are followed in the Cardiology Clinic at Akdeniz University Hospital.
Data Collection Instruments
The following data collection tools will be used in the study:
Patient Information Form: To collect demographic and clinical information. European Heart Failure Self-Care Behavior Scale-12: To assess self-care behaviors specific to heart failure.
General Self-Efficacy Scale: To measure perceived competence in coping with general difficulties.
Beliefs about Medication Adherence Scale: To evaluate patients' beliefs regarding adherence to medication.
Beliefs about Dietary Adherence Scale: To assess patients' beliefs concerning adherence to dietary recommendations.
Permissions for the use of the Turkish adaptations of these scales have been obtained via email from the authors responsible for their respective adaptations.
Intervention Program and Control Group An educational booklet, developed by the researcher based on a review of current research and evidence-based treatment guidelines, will be utilized for the training program, considering the specific needs of the patients.
Intervention Group: Patients in this group will receive a comprehensive educational program:
In-Hospital Individual Training: This will begin with a personalized training session conducted in the hospital, tailored to each patient's unique needs. The content of this session, covering self-efficacy, self-care, and medication and diet compliance, has been developed from an extensive review of up-to-date research and evidence-based treatment guidelines to ensure its effectiveness.
Post-Discharge Telephone Follow-up: After discharge, patients in the intervention group will receive six telephone calls over a three-month period, with two calls scheduled each month. These calls will help reinforce the in-hospital education and provide continuous support.
Control Group: This group will continue to receive routine nursing care and treatment in the Cardiology Clinic, without any additional educational interventions.
Data Collection Schedule
To measure the impact of the intervention, data will be collected twice for both groups:
Baseline: Data will be collected at the beginning of the study. Three Months Later: A second round of data collection will be conducted three months after the initial data collection.
- Conditions
- Heart Failure
- Being tested
- Nurse-led Patient Education
- Keywords
- Nursing, self-care, Nursing education, Nursing care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led Patient EducationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Nurse-led Patient Education |
| Control group | No intervention | control group routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
General Self-Efficacy Scale This scale is designed to assess an individual's perceived competence in dealing with general life difficulties. It's a 4-point Likert-type scale. Scores range from a minimum of 10 to a maximum of 40. A higher score on this scale indicates that the individual has a stronger perception of their own competence.
Beliefs About Diet and Medication Adherence Scales Both the Beliefs About Diet Adherence Scale and the Beliefs About Medication Adherence Scale are used to understand patients' beliefs regarding their adherence to dietary recommendations and medication regimens, respectively. Each of these scales comprises 12 items and uses a 5-point Likert-type scale.The minimum score on these scales is 12 and the maximum score is 60.
Higher scores on these scales indicate that the individual has stronger beliefs about adherence to diet or medication. Conversely, lower scores indicate weaker beliefs.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start15 Jul 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 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.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research is a randomized controlled experimental study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şengül Akdeniz, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032896
- Sponsor's protocol ID
- AU-IMN-SA-01
- Status last verified
- Jun 2026
- First submitted
- 26 May 2025
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'The Effect of Nurse-Led Education on Patients' Self-Care Behaviour, Self-Efficacy Level, Medication and Diet Compliance in Individuals With Heart Failure'.
- ClinicalTrials.gov ID
- NCT07032896
- Acronym / sponsor ID
- AU-IMN-SA-01
- Conditions
- Heart Failure
- Keywords
- Nursing, self-care, Nursing education, Nursing care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jun 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.
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.
Detailed description
This study, to be conducted at the Akdeniz University Hospital Cardiology Department and Outpatient Clinic, aims to evaluate the impact of nurse-led education on heart failure patients' self-efficacy, self-care behaviors, and adherence to medication and diet.
Study Population The study sample will comprise heart failure patients aged 18 years and older who are followed in the Cardiology Clinic at Akdeniz University Hospital.
Data Collection Instruments
The following data collection tools will be used in the study:
Patient Information Form: To collect demographic and clinical information. European Heart Failure Self-Care Behavior Scale-12: To assess self-care behaviors specific to heart failure.
General Self-Efficacy Scale: To measure perceived competence in coping with general difficulties.
Beliefs about Medication Adherence Scale: To evaluate patients' beliefs regarding adherence to medication.
Beliefs about Dietary Adherence Scale: To assess patients' beliefs concerning adherence to dietary recommendations.
Permissions for the use of the Turkish adaptations of these scales have been obtained via email from the authors responsible for their respective adaptations.
Intervention Program and Control Group An educational booklet, developed by the researcher based on a review of current research and evidence-based treatment guidelines, will be utilized for the training program, considering the specific needs of the patients.
Intervention Group: Patients in this group will receive a comprehensive educational program:
In-Hospital Individual Training: This will begin with a personalized training session conducted in the hospital, tailored to each patient's unique needs. The content of this session, covering self-efficacy, self-care, and medication and diet compliance, has been developed from an extensive review of up-to-date research and evidence-based treatment guidelines to ensure its effectiveness.
Post-Discharge Telephone Follow-up: After discharge, patients in the intervention group will receive six telephone calls over a three-month period, with two calls scheduled each month. These calls will help reinforce the in-hospital education and provide continuous support.
Control Group: This group will continue to receive routine nursing care and treatment in the Cardiology Clinic, without any additional educational interventions.
Data Collection Schedule
To measure the impact of the intervention, data will be collected twice for both groups:
Baseline: Data will be collected at the beginning of the study. Three Months Later: A second round of data collection will be conducted three months after the initial data collection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The research is a randomized controlled experimental study.
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Nurse-led Patient EducationThe 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. |
| Control group | No intervention | –control group routine care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
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 |
|---|---|---|
| Nurse-led Patient EducationThe 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 | Behavioural | intervention group |
Primary outcome
European Heart Failure Self-Care Behaviour Scale (EHFScBS)
Time frame: 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.
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).
1 secondary outcome
General Self-Efficacy (GSE), The Beliefs About Medication Compliance Scale (BMCS), The Beliefs About Dietary Compliance Scale (BDCS)
Time frame: 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.
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 3 Jun 2026.
- Individual participant dataSharing planned: No
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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 Nurse-led Patient Education in people with Heart Failure, run by Akdeniz University 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 8 inclusion and 6 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 3 Jun 2026. 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?
European Heart Failure Self-Care Behaviour Scale (EHFScBS) (time frame: 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.). 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 3 Jun 2026.