Education and Counseling Program on Patients With CIEDs and Low HL

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?

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 Overview

• Status: Recruiting
• Conditions: Heart Failure; Arrhythmias, Cardiac; Health Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Education and Counseling Program

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merve Erünal; Phone Number: +905544635942; Email: erunalmm@gmail.com
• Study Contact Backup: Name: Hatice Mert; Phone Number: +092324124786; Email: hatice.mert@deu.edu.tr

Study Locations

• Turkey
  • İzmir
    • Balçova, İzmir, Turkey
      • Recruiting
      • Merve Erunal
      • Contact: Merve Erunal, MSc; Phone Number: +905544635942; Email: erunalmm@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients who receive education and counseling program; Patients with CIEDs and low health literacy received education and counseling program by researchers.	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.; Other Names: Education and counseling program about living with CIEDs.
No Intervention: Patients who receive clinical routine care; Patients with CIEDs and low health literacy received only clinical routine care.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dokuz Eylul University
• Investigators: Principal Investigator: Merve Erünal, Dokuz Eylül University Faculty of Nursing; Principal Investigator: Hatice Mert, Dokuz Eylül University Faculty of Nursing

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 2018/16-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No