Education and Counseling Program on Patients With CIEDs and Low HL

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy

Conditions
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Arrhythmias, Cardiac, Heart Failure, Health Knowledge, Attitudes, Practice

Intervention / Treatment
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* Other: Education and Counseling Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Not literate having vision or hearing problem having psychiatric and cognitive impairment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients who receive education and counseling program<br>Patients with CIEDs and low health literacy received education and counseling program by researchers. | Other: Education and Counseling Program<br>* 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.<br>* Other names: Education and counseling program about living with CIEDs.;|
| No Intervention: Patients who receive clinical routine care<br>Patients with CIEDs and low health literacy received only clinical routine care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline knowledge level | CIEDs knowledge scale score of patients | Before education | 
| Change in knowledge level | CIEDs knowledge scale score of patients | At first month after education | 
| Change in knowledge level | CIEDs knowledge scale score of patients | At third month after education | 
| Change in knowledge level | CIEDs knowledge scale score of patients | At sixth month after education | 
| Baseline daily life activities | Duke Activity Index score of patients | Before education | 
| Change in daily life activities | Duke Activity Index score of patients | At first month after education | 
| Change in daily life activities | Duke Activity Index score of patients | At third month after education | 
| Change in daily life activities | Duke Activity Index score of patients | At sixth month after education | 
| Baseline health literacy level | Health Literacy Survey European Questionnaire 16 score of patients | Before education | 
| Change in health literacy level | Health Literacy Survey European Questionnaire 16 score of patients | At first month after education | 
| Change in health literacy level | Health Literacy Survey European Questionnaire 16 score of patients | At third month after education | 
| Change in health literacy level | Health Literacy Survey European Questionnaire 16 score of patients | At sixth month after education |