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

NCT06233721 | Completed

• 1 other identifier: CUharun
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Oral Anticoagulant Medication; Tele-education; Medication compliance; Medication satisfaction

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Control group

NO INTERVENTION

Identifying Information Form (IIF), Medication Adherence Report Scale (MARS), and Duke Anticoagulation Satisfaction Scale (DASS) were applied to the control group two times, once in the first interview and once in the interview held a month later. The control group was not provided with education. In line with ethical principles, education and education booklet was provided to this group after the scales were applied in the last interview held in the outpatient clinic control. The application of the scales took 20-25 minutes on average.

Face-to-face education group

EXPERIMENTAL

Identifying Information Form (IIF), Medication Adherence Report Scale (MARS), and Duke Anticoagulation Satisfaction Scale (DASS) were applied to the face-to-face group in the first interview. They were provided with face-to-face education on the determined date and in the specified environment. At the end of the education, education booklet was given to the individuals. Then, an appointment was made for a month later in hospital environment. In the interview held one month later, the scales were applied again for the last time.

Other: Face-to-face education

Online education group

EXPERIMENTAL

IIF, MARS, and DASS were also applied to the online education group in the first interview. On the predetermined date and time, online education was given to individuals through video calls held on TEAMS, Google MEET, or WhatsApp. Then, the education booklet was sent to the participants through the application. An appointment date was determined to have another interview a month later. In the interview held a month later, the relevant scales were applied for the last time. At the end of the education, an evaluation was made, and the parts that were seen to be deficient and the issues/questions that the participants raised were repeated. Accordingly, the individuals in both intervention groups were requested to come for control a month later, and the scales were applied for the last time. Education was provided to the participants by the same researcher using the two methods, and the same education content and booklet was used.

Other: Online education

Interventions

Online education OTHER

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.

Online education group

Face-to-face education OTHER

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.

Face-to-face education group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (1)

Ankara bilkent city hospital

Çankaya, (553)492-96-26, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial Fibrillation; Medication Adherence

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Individuals who agreed to participate in the study were randomly assigned to intervention and control groups by using a randomizer (http://www.randomization.com). 150 individuals who were included in the study were randomly split into three groups by a person other than the researcher, and the three groups were given a code name. In order to generate random numbers for randomization (from 1 to 50), a software was used. Thus, determined numbers for each group were obtained. Both the participants and the researchers were blinded in group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Student, Responsible Researcher

Model Details: Control group Intervention group 1 (face-to-face education group) Intervention group 2 (tele-education group)

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 31, 2024
• Study Start: May 1, 2022
• Primary Completion: July 7, 2022
• Study Completion: October 17, 2022
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)