Education and Counseling Program on Patients With CIEDs and Low HL

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05636956
• Other study ID #: 2018/16-34
• Status: Recruiting
• Phase: N/A
• Start date: June 26, 2022
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: Dokuz Eylul University
• Contact: Merve Erünal
• Phone: +905544635942
• Email: erunalmm[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Education and Counseling Program
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.

Locations

Country	Name	City	State
Turkey	Merve Erunal	Balçova	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline knowledge level	CIEDs knowledge scale score of patients	Before education
Primary	Change in knowledge level	CIEDs knowledge scale score of patients	At first month after education
Primary	Change in knowledge level	CIEDs knowledge scale score of patients	At third month after education
Primary	Change in knowledge level	CIEDs knowledge scale score of patients	At sixth month after education
Primary	Baseline daily life activities	Duke Activity Index score of patients	Before education
Primary	Change in daily life activities	Duke Activity Index score of patients	At first month after education
Primary	Change in daily life activities	Duke Activity Index score of patients	At third month after education
Primary	Change in daily life activities	Duke Activity Index score of patients	At sixth month after education
Primary	Baseline health literacy level	Health Literacy Survey European Questionnaire 16 score of patients	Before education
Primary	Change in health literacy level	Health Literacy Survey European Questionnaire 16 score of patients	At first month after education
Primary	Change in health literacy level	Health Literacy Survey European Questionnaire 16 score of patients	At third month after education
Primary	Change in health literacy level	Health Literacy Survey European Questionnaire 16 score of patients	At sixth month after education