Atrial FibrillationNCT06233721
The Effect Of Face-To-Face and Online-Education Provided To İndividuals With Atrial Fibrillation On Medication Adherence and Satisfaction
A study testing Online education and Face-to-face education in people with Atrial Fibrillation, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Online education and Face-to-face education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 17 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- The individuals who had disorders that would affect training and experienced complications such as active hemorrhage related to oral anticoagulant use
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara bilkent city hospital
Çankaya, (553)492-96-26
About this study
Official title: Master's Degree Graduate Nurse PhD Student
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.
Read more
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.
Read the detailed 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Online education, Face-to-face education
- Keywords
- Atrial Fibrillation, Oral Anticoagulant Medication, Tele-education, Medication compliance, Medication satisfaction
- Medical subject headings
- Atrial Fibrillation, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online educationOther
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 educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Online education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.
Measured: 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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 May 2022
- Primary completion7 Jul 2022
- Study completion17 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control group Intervention group 1 (face-to-face education group) Intervention group 2 (tele-education group)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Küçükballı, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233721
- Sponsor's protocol ID
- CUharun
- Status last verified
- Jan 2024
- First submitted
- 29 Nov 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Master's Degree Graduate Nurse PhD Student
- ClinicalTrials.gov ID
- NCT06233721
- Acronym / sponsor ID
- CUharun
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Oral Anticoagulant Medication, Tele-education, Medication compliance, Medication satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 7 Jul 2022 (actual)
- Study completion
- 17 Oct 2022 (actual)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Control group Intervention group 1 (face-to-face education group) Intervention group 2 (tele-education group)
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Face-to-face educationIdentifying 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. |
| Online education group | Experimental | Other: Online educationIIF, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- The individuals who had disorders that would affect training and experienced complications such as active hemorrhage related to oral anticoagulant use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online educationEducation 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. | Other | Online education group |
| Face-to-face educationEducation 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. | Other | Face-to-face education group |
Primary outcome
Identifying Information Form (IIF)
Time frame: 1 month
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.)
Medication Adherence Report Scale (MARS)
Time frame: 1 month
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.
Duke Anticoagulation Satisfaction Scale (DASS)
Time frame: 1 month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online education and Face-to-face education in people with Atrial Fibrillation, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identifying Information Form (IIF) (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.