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

NCT ID: NCT06233721

Last Updated: 2024-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-10-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group Intervention group 1 (face-to-face education group) Intervention group 2 (tele-education group)
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Face-to-face education group

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.

Group Type EXPERIMENTAL

Face-to-face education

Intervention Type 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.

Online education group

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.

Group Type EXPERIMENTAL

Online education

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Cumhuriyet University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Harun Küçükballı

Graduate Student, Responsible Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ankara bilkent city hospital

Çankaya, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CUharun

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Video Intervention Fertility Awareness Training
NCT06541717 NOT_YET_RECRUITING NA