Education and Counseling Program on Patients With CIEDs and Low HL

NCT05636956 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-12-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Dokuz Eylul University

    lead OTHER

Principal Investigators

  • Merve Erünal · Dokuz Eylul University Faculty of Nursing

  • Hatice Mert · Dokuz Eylul University Faculty of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-26
Primary Completion
2023-05-31
Completion
2023-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05636956 on ClinicalTrials.gov