Effect of Planned Visual Training on Heart Failure Patients

January 29, 2025 updated by: Dilan Deniz Akan, Celal Bayar University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Manisa, Turkey, 45000
        • Manisa Celal Bayar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
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).
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:
  • Educational intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

Pre-test

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection tool
Time Frame: 3 month

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Data collection tool
Time Frame: 6-months / Post-test

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Actual)

March 30, 2022

Study Completion (Actual)

March 30, 2022

Study Registration Dates

First Submitted

December 26, 2024

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

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)?

YES

IPD Plan Description

It can be shared upon request, if the relevant ethics committee approves.

IPD Sharing Time Frame

starting 6 months after publication

IPD Sharing Access Criteria

It can be shared upon request, if the relevant ethics committee approves.

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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