- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06807671
Effect of Planned Visual Training on Heart Failure Patients
Does Planned Visual Training Affect the Attitudes, Beliefs and Symptoms of Individuals with Heart Failure Towards Their Disease?
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Manisa, Turkey, 45000
- Manisa Celal Bayar University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control Group
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.
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Experimental: Experimental Group
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).
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Data collection tool
Time Frame: Pre-test
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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. |
Pre-test
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Data collection tool
Time Frame: 3 month
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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. |
3 month
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Data collection tool
Time Frame: 6-months / Post-test
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In the 6th month of the study, after the educational intervention was completed, data were collected again from the intervention and control groups through data collection forms. HBM-HF: The scale was developed to assess the attitudes and beliefs of HF patients towards their disease. The scale consists of 24 items and five sub-dimensions (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, self-efficacy) and is a five-point Likert-type scale. The items of the perceived barrier sub-dimension in the scale are reverse coded. The scale does not have a total score and each sub-dimension is calculated independently. Higher scores indicate higher perception of susceptibility, perceived severity, perceived benefits, and good self-efficacy, while lower scores indicate stronger perception of barriers. The Cronbach's alpha coefficients of the sub-dimensions are 0.91, 0.86, 0.88, 0.75, and 0.84, respectively. |
6-months / Post-test
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCBU dilan deniz akan
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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