Education and Counseling Program on Patients With CIEDs and Low HL

Sponsor

Dokuz Eylul University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05636956

Collaborator

(none)

Enrollment

Location

Arms

12.2

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arrhythmias, Cardiac Heart Failure Health Knowledge, Attitudes, Practice	Other: Education and Counseling Program	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized controlled trialRandomized controlled trial

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 26, 2022

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merve Erunal	Balçova	İzmir	Turkey

Sponsors and Collaborators

Dokuz Eylul University

Investigators

Principal Investigator: Merve Erünal, Dokuz Eylul University Faculty of Nursing
Principal Investigator: Hatice Mert, Dokuz Eylul University Faculty of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merve Erunal, Research Assistant, MSc., PhD(c)., Dokuz Eylul University

ClinicalTrials.gov Identifier:

NCT05636956

Other Study ID Numbers:

2018/16-34

First Posted:

Dec 5, 2022

Last Update Posted:

Dec 5, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arrhythmias, Cardiac

Study Results

No Results Posted as of Dec 5, 2022