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Clinical Trials/NCT05636956
NCT05636956
Recruiting
N/A

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

Dokuz Eylul University1 site in 1 country60 target enrollmentJune 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Arrhythmias, Cardiac
Sponsor
Dokuz Eylul University
Enrollment
60
Locations
1
Primary Endpoint
Baseline health literacy level
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 26, 2022
End Date
July 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Merve Erunal

Research Assistant, MSc., PhD(c).

Dokuz Eylul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Baseline health literacy level

Time Frame: Before education

Health Literacy Survey European Questionnaire 16 score of patients

Change in daily life activities

Time Frame: At sixth month after education

Duke Activity Index score of patients

Baseline knowledge level

Time Frame: Before education

CIEDs knowledge scale score of patients

Change in health literacy level

Time Frame: At sixth month after education

Health Literacy Survey European Questionnaire 16 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

Study Sites (1)

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