Education and Counseling Program on Patients With CIEDs and Low HL

Not Applicable

Recruiting

• Conditions: Arrhythmias, Cardiac; Heart Failure; Health Knowledge, Attitudes, Practice
• Interventions: Other: Education and Counseling Program

• Registration Number: NCT05636956
• Lead Sponsor: Dokuz Eylul University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-26
• Status Verified: 2022-11
• Study First Submitted: 2022-11-16
• Study First Submitted QC: 2022-11-24
• Last Update Submitted: 2022-11-24
• Study First Posted: 2022-12-05
• Last Update Posted: 2022-12-05
• Primary Completion: 2023-05
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who receive education and counseling program	Education and Counseling Program	Patients with CIEDs and low health literacy received education and counseling program by researchers.

Primary Outcome Measures

Name	Time	Method
Change in daily life activities	At sixth month after education	Duke Activity Index score of patients
Baseline health literacy level	Before education	Health Literacy Survey European Questionnaire 16 score of patients
Baseline knowledge level	Before education	CIEDs knowledge scale score of patients
Change in knowledge level	At sixth month after education	CIEDs knowledge scale score of patients
Baseline daily life activities	Before education	Duke Activity Index score of patients
Change in health literacy level	At sixth month after education	Health Literacy Survey European Questionnaire 16 score of patients

Trial Locations

Locations (1)

Merve Erunal; 🇹🇷 Balçova, İzmir, Turkey