Heart FailureNCT06807671
Effect of Planned Visual Training on Heart Failure Patients
A study testing Experimental Group in people with Heart Failure, run by Manisa Celal Bayar University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of heart failure patients towards their disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Experimental Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Mar 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 65,
- Those with no communication problems,
- Those diagnosed with NYHA I-II heart failure,
- Those without cognitive impairment,
- Those who can understand and speak Turkish,
- Those who agree to participate in the study.
Who cannot join
- Patients who do not agree to participate in the study,
- Patients who want to leave the study,
- Patients with NYHA III-IV heart failure diagnosis,
- Patients diagnosed with cancer,
- Patients with diabetic foot or amputation.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Manisa Celal Bayar University
Manisa, Manisa, 45000
About this study
Official title: Does Planned Visual Training Affect the Attitudes, Beliefs and Symptoms of Individuals with Heart Failure Towards Their Disease?
This study was conducted to evaluate the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of heart failure patients towards their disease. Planned visual education based on the Health Belief Model has positive effects on the attitudes, beliefs, and symptoms of heart failure patients towards their disease.
Read the detailed description
This study, which evaluated the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of patients with heart failure towards their disease, was conducted with 110 heart failure patients. The study was planned as a randomized controlled experimental study conducted on two groups as intervention (n = 55) and control group (n = 55). The study was conducted between September 2021 and March 2022 at Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic. Simple randomization method was used in assigning the sample group to the experimental and control groups. Data were collected using "the Patient Identification Form", "the Health Belief Model Scale - Heart Failure" and "Memorial Symptom Assessment Scale - Heart Failure".
- Conditions
- Heart Failure
- Being tested
- Experimental Group
- Keywords
- heart failure, health belief model, patient training, nursing
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental GroupOther
Also called Educational intervention
Patients in the intervention group received HBM based training for a period of 6 months. During the training, one-on-one interviews were provided with each patient. Patients were shown a power point presentation, a brochure, and 3 training videos. Any questions patients had were answered one-on-one.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | No Intervention: Control group No intervention was made by the researcher during the study. Only data was collected. At the end of the study, visual training based on the planned Health Belief Model was given and all patients who continued the study were given brochures and heart-shaped key chains designed by the researchers. |
| Experimental Group | Experimental | Experimental: intervention group The sample of this simple-randomized controlled experimental study consisted of heart failure patients who applied to Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic between September 2021 and March 2022. Patients who were determined by drawing lots according to their protocol numbers using the simple random sampling method were assigned to the intervention group. Patients assigned to the intervention group were given planned training based on the Health Belief Model. The intervention group was followed up for six months. A total of three interviews were conducted with the intervention group (First interview, 3rd month interview and 6th month interview). Receives: Other: Experimental Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection tool
In order to monitor the effectiveness of the intervention in the study, a 6-month follow-up was conducted and data were collected from the intervention group 3 times (before the intervention, at 3 months and at 6 months) and from the control group twice (at the first interview and at 6 months) through data collection forms.
HBM-based education program was applied to the intervention group as an intervention.
Data collection tools were "Patient Information Form", "Memorial Symptom Assessment Scale - Heart Failure (MSAS-HF)" and "Health Belief Model Scale in Heart Failure (HBM-HF)".
Patient Information Form: A total of 15 questions are included, including sociodemographic information (such as age, gender, marital status, education status, employment status, occupation and income status) and additional information regarding HF/HF treatment (perceived health status, compliance with diet, exercise, treatment compliance, regular doctor visits, etc.) of the participants.
Measured: Pre-test
Secondary outcomes (1)
Data collection tool
In the study, 3-month data were collected from the intervention group using the same measurement tools.
MSAS-HF: The scale is used to evaluate the symptoms experienced by patients with HF. It consists of three sub-dimensions in total (physical symptoms, psychological symptoms, and HF symptoms). For the symptoms encountered, it is expected to rate the frequency and severity of the symptom with a four-point Likert-type assessment, and the discomfort with a five-point Likert-type assessment. In the calculation, symptom load is first calculated for each symptom. The load of the unseen symptom is evaluated as zero. The Cronbach alpha values of the scale were reported as 0.53 for physical symptoms, 0.63 for psychological symptoms, and 0.55 for HF symptoms.
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start1 Sep 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilan Deniz Akan, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807671
- Sponsor's protocol ID
- MCBU dilan deniz akan
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2024
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It can be shared upon request, if the relevant ethics committee approves.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Planned Visual Training Affect the Attitudes, Beliefs and Symptoms of Individuals with Heart Failure Towards Their Disease?
- ClinicalTrials.gov ID
- NCT06807671
- Acronym / sponsor ID
- MCBU dilan deniz akan
- Conditions
- Heart Failure
- Keywords
- heart failure, health belief model, patient training, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 4 Feb 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 was conducted to evaluate the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of heart failure patients towards their disease. Planned visual education based on the Health Belief Model has positive effects on the attitudes, beliefs, and symptoms of heart failure patients towards their disease.
Detailed description
This study, which evaluated the effects of planned visual education based on the Health Belief Model on the attitudes, beliefs, and symptoms of patients with heart failure towards their disease, was conducted with 110 heart failure patients. The study was planned as a randomized controlled experimental study conducted on two groups as intervention (n = 55) and control group (n = 55). The study was conducted between September 2021 and March 2022 at Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic. Simple randomization method was used in assigning the sample group to the experimental and control groups. Data were collected using "the Patient Identification Form", "the Health Belief Model Scale - Heart Failure" and "Memorial Symptom Assessment Scale - Heart Failure".
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No Intervention: Control group No intervention was made by the researcher during the study. Only data was collected. At the end of the study, visual training based on the planned Health Belief Model was given and all patients who continued the study were given brochures and heart-shaped key chains designed by the researchers. |
| Experimental Group | Experimental | Other: Experimental GroupExperimental: intervention group The sample of this simple-randomized controlled experimental study consisted of heart failure patients who applied to Manisa Celal Bayar University (MCBU) Hafsa Sultan Hospital Cardiology Polyclinic between September 2021 and March 2022. Patients who were determined by drawing lots according to their protocol numbers using the simple random sampling method were assigned to the intervention group. Patients assigned to the intervention group were given planned training based on the Health Belief Model. The intervention group was followed up for six months. A total of three interviews were conducted with the intervention group (First interview, 3rd month interview and 6th month interview). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients aged between 18 and 65,
- Those with no communication problems,
- Those diagnosed with NYHA I-II heart failure,
- Those without cognitive impairment,
- Those who can understand and speak Turkish,
Key exclusion criteria (5 listed)
- Patients who do not agree to participate in the study,
- Patients who want to leave the study,
- Patients with NYHA III-IV heart failure diagnosis,
- Patients diagnosed with cancer,
- Patients with diabetic foot or amputation.
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 |
|---|---|---|
| Experimental GroupAlso: Educational interventionPatients in the intervention group received HBM based training for a period of 6 months. During the training, one-on-one interviews were provided with each patient. Patients were shown a power point presentation, a brochure, and 3 training videos. Any questions patients had were answered one-on-one. | Other | Experimental Group |
Primary outcome
Data collection tool
Time frame: Pre-test
In order to monitor the effectiveness of the intervention in the study, a 6-month follow-up was conducted and data were collected from the intervention group 3 times (before the intervention, at 3 months and at 6 months) and from the control group twice (at the first interview and at 6 months) through data collection forms. HBM-based education program was applied to the intervention group as an intervention. Data collection tools were "Patient Information Form", "Memorial Symptom Assessment Scale - Heart Failure (MSAS-HF)" and "Health Belief Model Scale in Heart Failure (HBM-HF)". Patient Information Form: A total of 15 questions are included, including sociodemographic information (such as age, gender, marital status, education status, employment status, occupation and income status) and additional information regarding HF/HF treatment (perceived health status, compliance with diet, exercise, treatment compliance, regular doctor visits, etc.) of the participants.
1 secondary outcome
Data collection tool
Time frame: 3 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 4 Feb 2025.
- Individual participant dataSharing planned: Yes. It can be shared upon request, if the relevant ethics committee approves.
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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 Experimental Group in people with Heart Failure, run by Manisa Celal Bayar 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 6 inclusion and 5 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 4 Feb 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?
Data collection tool (time frame: Pre-test). 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 4 Feb 2025.