The Effect of Education on Symptom Burden, Medication Adherence, and Nutritional Behaviour
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to determine the effect of online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. The sample size was calculated using the 'G. Power-3.1.9.2' programme at a 95% confidence level prior to data collection. Accordingly, the minimum sample size required for the independent sample t-test for the study was determined to be 44 (22 for each group) based on an alpha value of 0.05, an effect size of 1.128, and a theoretical power of 95%. Taking data losses into account, a total of 60 patients (30 for each group) were planned to be included in the sample. Data will be collected using the Heart Failure Symptom Status Scale, Medication Adherence and Prescription Printing Scale (İURYÖ-7), Heart Failure Nutrition Behaviour Scale. 1: Prior to providing education to patients, they will be informed about the purpose of the study, the data collection method, and the topics to be covered in the education. Patients who agree to participate in the study will be asked to sign an informed consent form. All patients in the experimental and control groups will be asked to complete the Heart Failure Nutrition Behaviour Scale (HFNBS), Heart Failure Symptom Status Scale (HFSSS), and Medication Adherence and Prescription Writing Scale (MAPWS-79) before receiving education. 2: The contact information of all patients in the experimental group will be collected. Training will be provided online at a time and date convenient for the patients. 3: Patients in the control group will receive a digital training booklet prepared by the researcher at the contact address they provide. 4: Participants will be contacted 2 weeks, 1 month, and 2 months after the initial education session to obtain feedback on post-education dietary behaviours, medication adherence, and symptoms. 5: Four to six weeks after the training is completed, the 'Nutritional Behaviour Scale in Heart Failure,' 'Heart Failure Symptom Status Scale,' and 'Medication Adherence and Prescription Writing Scale (İURYÖ-7)' will be completed online again. The same forms will also be completed online by patients in the control group 4-6 weeks later.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2025
CompletedFirst Posted
Study publicly available on registry
June 12, 2025
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJune 13, 2025
June 1, 2025
2 months
June 4, 2025
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Heart Failure Symptom Status Scale
The scale addresses seven primary symptoms: dyspnoea, dyspnoea when lying supine, fatigue, chest pain, oedema, sleep problems, dizziness, and loss of balance.The total score that can be obtained from the scale ranges from 0 to 84. An increase in the score indicates a greater symptom burden.
Baseline and after 6 months
Medication Adherence and Prescription Writing Scale
The scale can also be used to determine medication adherence in individuals with low literacy levels. The scale consists of two subscales: the medication adherence subscale ranges from 4 to 16 points, and the prescription subscale ranges from 3 to 12 points. Item 7 is reverse-coded in the scale.The scale consists of 7 items, with the lowest possible score being 7 and the highest possible score being 28. As the score obtained from the scale decreases, medication adherence increases.
Baseline and after 6 months
Heart Failure Nutrition Behaviour Scale
The HFNBS consists of four subscales: healthy habits, salt restriction, sugar restriction, and prevention of retention, and comprises a total of 19 items. . A high total score on the scale indicates that individuals have adopted a diet consistent with the recommended dietary guidelines for heart failure; a low score indicates that individuals are not following these recommendations. The interpretation of the scores is as follows: * 19 ≤ score \<46: Patients are not following the guidelines and expert recommendations. * 46 ≤ score \<51: Patients are following the guidelines and expert recommendations to some extent. * 51 ≤ score \<55: Patients are following the guidelines and expert recommendations to a moderate extent. * 55 ≤ score ≤76: Patients are following the guidelines and expert recommendations to a high extent.
Baseline and after 6 months
Study Arms (2)
Intervetion group
EXPERIMENTALThe intervention group will consist of 30 people. The intervention group will receive 45 minutes online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. Two weeks, one month, and two months after the initial education, participants will be contacted to obtain feedback on their post-education dietary behaviours, medication compliance, and symptoms.
Control group
NO INTERVENTIONThe control group will consist of 30 people. All patients will be asked to complete the Heart Failure Symptom Status Scale, Medication Adherence and Prescription Writing Scale. Patients in the control group will not receive any training. The same forms will be filled out for the final test 3 months later. Patients who wish to will be given the training provided in the experimental group.
Interventions
intervention group will receive 45 minutes online education structured according to Pender's Health Promotion Model on symptom burden, medication adherence, and nutritional behaviour in patients with heart failure. Two weeks, one month, and two months after the initial education, participants will be contacted to obtain feedback on their post-education dietary behaviours, medication compliance, and symptoms.
Eligibility Criteria
You may qualify if:
- Volunteering to participate in the study.
- Diagnosed with heart failure.
- Not having cognitive dysfunction.
- Access to the internet and the technical infrastructure to participate in online training.
You may not qualify if:
- Having severe cognitive or psychological disorders,
- Having difficulty communicating,
- Being in the process of heart transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Naile ALANKAYAlead
Study Sites (1)
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Merkez, Çanakkale, 17100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
NAİLE ALANKAYA, Assoc. Prof
Çanakkale Onsekiz Mart University, Faculty of Health Sciences
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assoc. Prof.
Study Record Dates
First Submitted
June 4, 2025
First Posted
June 12, 2025
Study Start
July 15, 2025
Primary Completion
September 15, 2025
Study Completion
December 30, 2025
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share