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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05636956
Enrollment
60
Registered
2022-12-05
Start date
2022-06-26
Completion date
2023-07-31
Last updated
2022-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEREducation 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

Dokuz Eylul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Baseline knowledge levelBefore educationCIEDs knowledge scale score of patients
Change in knowledge levelAt first month after educationCIEDs knowledge scale score of patients
Baseline daily life activitiesBefore educationDuke Activity Index score of patients
Change in daily life activitiesAt first month after educationDuke Activity Index score of patients
Baseline health literacy levelBefore educationHealth Literacy Survey European Questionnaire 16 score of patients
Change in health literacy levelAt first month after educationHealth Literacy Survey European Questionnaire 16 score of patients

Countries

Turkey (Türkiye)

Contacts

Primary ContactMerve Erünal
erunalmm@gmail.com+905544635942
Backup ContactHatice Mert
hatice.mert@deu.edu.tr+092324124786

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026