Arrhythmias, CardiacNCT05636956
Education and Counseling Program on Patients With CIEDs and Low HL
A study testing Education and Counseling Program in people with Arrhythmias, Cardiac and Heart Failure, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Arrhythmias, Cardiac, Heart Failure, Health Knowledge, Attitudes, Practice
- What is being tested?
- Education and Counseling Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2022to Jul 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no communication problems in Turkish
- implanted any type of CIED for the first time
- having low score of HLS EU Q16
- willingness to participate in the study
Who cannot join
- Not literate
- having vision or hearing problem
- having psychiatric and cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Merve Erunal
Balçova, İzmir
Merve Erunal, MSc, +905544635942, erunalmm@gmail.com
About this study
Official title: The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy.
The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program?
Read more
Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation.
Reseraches compare scores between intervention and control groups, also different times in same groups.
- Being tested
- Education and Counseling Program
- Medical subject headings
- Arrhythmias, Cardiac, Heart Failure, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Counseling ProgramOther
Also called Education and counseling program about living with CIEDs.
Researches created an education and counseling program. In this context, patients receive an one hour education. Education program consist of face-to-face informing and teach-back method. At the end of the face-to-face informing, researchers give a comicbook about instructions of living with CIEDs as a written material. After discharge, researches follow-up patients with phone calls. In the context of phone calls researches continue to informing patients, remind related instructions for that time and answer questions of patients. Patients are allowed to reach reserarches any time if they have any concern or question. This program lasts for six months.
| Study group | Role | What they receive |
|---|---|---|
| Patients who receive education and counseling program | Experimental | Patients with CIEDs and low health literacy received education and counseling program by researchers. Receives: Other: Education and Counseling Program |
| Patients who receive clinical routine care | No intervention | Patients with CIEDs and low health literacy received only clinical routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline knowledge level
CIEDs knowledge scale score of patients
Measured: Before education
Change in knowledge level
CIEDs knowledge scale score of patients
Measured: At first month after education
Change in knowledge level
CIEDs knowledge scale score of patients
Measured: At third month after education
Change in knowledge level
CIEDs knowledge scale score of patients
Measured: At sixth month after education
Baseline daily life activities
Duke Activity Index score of patients
Measured: Before education
Change in daily life activities
Duke Activity Index score of patients
Measured: At first month after education
Change in daily life activities
Duke Activity Index score of patients
Measured: At third month after education
Change in daily life activities
Duke Activity Index score of patients
Measured: At sixth month after education
Baseline health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Measured: Before education
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Measured: At first month after education
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Measured: At third month after education
Change in health literacy level
Health Literacy Survey European Questionnaire 16 score of patients
Measured: At sixth month after education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start26 Jun 2022
- Primary completionMay 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmias, CardiacStudies 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
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Erunal, Dokuz Eylul University
- Investigators
- Merve Erünal, Principal investigator, Dokuz Eylul University Faculty of NursingHatice Mert, Principal investigator, Dokuz Eylul University Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05636956
- Sponsor's protocol ID
- 2018/16-34
- Status last verified
- Nov 2022
- First submitted
- 16 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
- ClinicalTrials.gov ID
- NCT05636956
- Acronym / sponsor ID
- 2018/16-34
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 26 Jun 2022 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 5 Dec 2022 (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.
The goal of this RCT (randomized controlled trial) is to investigate the effect of education and counseling program that researches developed on patients with cardiac implantable electronic devices (CIEDs) and low health literacy.
The main questions are; Is there a difference between the health literacy scores of intervention and control groups after education and counseling program? Is there a difference between the CIEDs knowledge scores of intervention and control groups after education and counseling program? Is there a difference between the daily life activity scores of intervention and control groups after education and counseling program?
Researches offer an education and counseling program about living with CIEDs to patients that having CIEDs for the first time. Participants answers questions in Health Literacy Survey European Questionnaire 16, cardiac implantable electronic devices knowledge scale (researches developed) and Duke Activity Index before education and counseling program, at first month, third month and sixth month after implantation.
Reseraches compare scores between intervention and control groups, also different times in same groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Patients who receive education and counseling program | Experimental | Other: Education and Counseling ProgramPatients with CIEDs and low health literacy received education and counseling program by researchers. |
| Patients who receive clinical routine care | No intervention | –Patients with CIEDs and low health literacy received only clinical routine care. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no communication problems in Turkish
- implanted any type of CIED for the first time
- having low score of HLS EU Q16
- willingness to participate in the study
Key exclusion criteria (3 listed)
- Not literate
- having vision or hearing problem
- having psychiatric and cognitive impairment
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 |
|---|---|---|
| Education and Counseling ProgramAlso: Education and counseling program about living with CIEDs.Researches created an education and counseling program. In this context, patients receive an one hour education. Education program consist of face-to-face informing and teach-back method. At the end of the face-to-face informing, researchers give a comicbook about instructions of living with CIEDs as a written material. After discharge, researches follow-up patients with phone calls. In the context of phone calls researches continue to informing patients, remind related instructions for that time and answer questions of patients. Patients are allowed to reach reserarches any time if they have any concern or question. This program lasts for six months. | Other | Patients who receive education and counseling program |
Primary outcome
Baseline knowledge level
Time frame: Before education
CIEDs knowledge scale score of patients
Change in knowledge level
Time frame: At first month after education
CIEDs knowledge scale score of patients
Change in knowledge level
Time frame: At third month after education
CIEDs knowledge scale score of patients
Change in knowledge level
Time frame: At sixth month after education
CIEDs knowledge scale score of patients
Baseline daily life activities
Time frame: Before education
Duke Activity Index score of patients
Change in daily life activities
Time frame: At first month after education
Duke Activity Index score of patients
Change in daily life activities
Time frame: At third month after education
Duke Activity Index score of patients
Change in daily life activities
Time frame: At sixth month after education
Duke Activity Index score of patients
Baseline health literacy level
Time frame: Before education
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Time frame: At first month after education
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Time frame: At third month after education
Health Literacy Survey European Questionnaire 16 score of patients
Change in health literacy level
Time frame: At sixth month after education
Health Literacy Survey European Questionnaire 16 score of patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
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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.
Merve Erünal principal investigator
Dokuz Eylul University Faculty of Nursing
Hatice Mert principal investigator
Dokuz Eylul University Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Counseling Program in people with Arrhythmias, Cardiac and Heart Failure, run by Dokuz Eylul 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 5 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Merve Erünal (+905544635942, erunalmm@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline knowledge level (time frame: Before education). The study lists 12 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 5 Dec 2022.