The Effect Of Face-To-Face and Online-Education Provided To İndividuals With Atrial Fibrillation On Medication Adherence and Satisfaction

Atrial Fibrillation Clinical Trial

Official title:

Master's Degree Graduate Nurse PhD Student

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06233721
• Other study ID #: CUharun
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: October 17, 2022

Study information

• Verified date: January 2024
• Source: Cumhuriyet University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled study was conducted to investigate the effects of face-to-face Education and tele-education given to individuals with atrial fibrillation taking oral Anticoagulants on their medication compliance and satisfaction levels. The study sample comprised 150 individuals. Of them, 50 were assigned to the control Group, 50 in the experimental group 1, and 50 for the experimental group 2. Data were collected by the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 Was given face-to-face education. The Intervention Group 2 was given tele-education. The control group underwent no intervention.

Description:

This randomized controlled study was conducted to investigate effects of face-to-face education and tele-education given to individuals with atrial fibrillation taking oral anticoagulants on their medication compliance and satisfaction levels. The study sample comprised 150 individuals. Of them, 50 were assigned to the control group, 50 to the experimental group 1, and 50 to the experimental group 2. Data were collected with the Descriptive Information Form, Medication Compliance Notification Scale and Duke Anticoagulant Satisfaction Scale. The Intervention Group 1 was given face-to-face education. The Intervention Group 2 was given tele-education. The control group underwent no intervention. The scales were administered to all the groups twice, at the first and last interviews. Frequency, percentage calculation, Chi-square test, significance test between two means, one-way analysis of variance, Wilcoxon sign test, Fisher test, Bonferroni test and dependent groups t test were used in the analysis of data. The intra-group analysis demonstrated that the Medication Compliance Notification Scale score of the intervention group 1 (face-to-face education group) increased significantly in the final measurement compared to those of the control group and intervention group 2 (tele-education group) (p=.000). The inter-group analysis demonstrated that Duke Anticoagulant Satisfaction Scale scores of the three groups statistically significantly different. The difference stemmed from the intervention group 1. Face-to-face education given to individuals with atrial fibrillation on oral anticoagulants improved their medication compliance and medication satisfaction levels. Nurses should primarily use face-to-face education in the care and education programs of individuals with atrial fibrillation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 17, 2022
• Est. primary completion date: July 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years and over
• Diagnosed with Atrial fibrillation (AF) for at least a year
• Had been using oral anticoagulant (OACs) for at least 3 months
• Had a smart phone
• Had not previously taken any training on oral anticoagulant medication treatment

Exclusion Criteria:

• The individuals who had disorders that would affect training and experienced complications such as active hemorrhage related to oral anticoagulant use

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Online education
Education content was prepared by the researchers by reviewing the literature. Education content included topics such as oral anticoagulant (OAC) medication introduction, OAC medication use, duration of use, most frequently seen side effects, interaction with other medications and foods, and points to consider while using the medication. While preparing the education content, expert opinions of five nurse academicians were taken. Evaluation of expert opinion was made through the form for Evaluation of the Appropriateness of Printed Materials and Discern. This education content created was provided to the face-to-face and online education groups in one session. Education sessions lasted approximately for 25-30 minutes.
• Face-to-face education
Education content was prepared by the researchers by reviewing the literature. Education content included topics such as OAC medication introduction, OAC medication use, duration of use, most frequently seen side effects, interaction with other medications and foods, and points to consider while using the medication. While preparing the education content, expert opinions of five nurse academicians were taken. Evaluation of expert opinion was made through the form for Evaluation of the Appropriateness of Printed Materials and Discern. This education content created was provided to the face-to-face and online education groups in one session. Education sessions lasted approximately for 25-30 minutes.

Locations

Country	Name	City	State
Turkey	Ankara bilkent city hospital	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identifying Information Form (IIF)	The form developed by the researchers by reviewing the literature consisted of 14 questions regarding the individuals' sociodemographic characteristics (age, gender, marital status, occupation, etc.) and disease characteristics (presence of a chronic disease, etc.)	1 month
Primary	Medication Adherence Report Scale (MARS)	The 5-point Likert type scale has five items. The total scale score is calculated by summing all item scores. The score to be obtained from the scale ranges between 5-25. High scores obtained from the scale show better medication adherence.	1 month
Primary	Duke Anticoagulation Satisfaction Scale (DASS)	The 7-point Likert type scale has 25 items under three subscales. High scores obtained from the scale show low medication satisfaction. The highest and lowest scores to be obtained from the scale are 175 and 25, respectively.	1 month