CClinicalTrials.gg
Status unknownNCT05636956Updated Dec 5, 2022

Education and Counseling Program on Patients With CIEDs and Low HL

An interventional study of Education and Counseling Program in Arrhythmias, Cardiac, Heart Failure and Health Knowledge, Attitudes, Practice, sponsored by Dokuz Eylul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-12-05.

Sponsored by Dokuz Eylul University · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jun 2022, registered Nov 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

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

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03

In context

Arrhythmias, Cardiac

885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.

This study's planned enrollment of 60 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.

Browse Arrhythmias, Cardiac studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Not literate
  • having vision or hearing problem
  • having psychiatric and cognitive impairment
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • No intervention
    Patients who receive clinical routine care

    Patients with CIEDs and low health literacy received only clinical routine care.

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.

    Also known as: Education and counseling program about living with CIEDs.

06

What researchers measure

Primary outcomes

  1. Baseline knowledge level

    CIEDs knowledge scale score of patients

    Time frame: Before education

  2. Change in knowledge level

    CIEDs knowledge scale score of patients

    Time frame: At first month after education

  3. Change in knowledge level

    CIEDs knowledge scale score of patients

    Time frame: At third month after education

  4. Change in knowledge level

    CIEDs knowledge scale score of patients

    Time frame: At sixth month after education

  5. Baseline daily life activities

    Duke Activity Index score of patients

    Time frame: Before education

  6. Change in daily life activities

    Duke Activity Index score of patients

    Time frame: At first month after education

  7. Change in daily life activities

    Duke Activity Index score of patients

    Time frame: At third month after education

  8. Change in daily life activities

    Duke Activity Index score of patients

    Time frame: At sixth month after education

  9. Baseline health literacy level

    Health Literacy Survey European Questionnaire 16 score of patients

    Time frame: Before education

  10. Change in health literacy level

    Health Literacy Survey European Questionnaire 16 score of patients

    Time frame: At first month after education

  11. Change in health literacy level

    Health Literacy Survey European Questionnaire 16 score of patients

    Time frame: At third month after education

  12. Change in health literacy level

    Health Literacy Survey European Questionnaire 16 score of patients

    Time frame: At sixth month after education

07

Study locations

1 of 1 sites recruiting
  • Merve Erunal
    Balçova, İzmir, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05636956
Lead sponsor
Dokuz Eylul University
Responsible party
Merve Erunal (Research Assistant, MSc., PhD(c)., Dokuz Eylul University) — Principal investigator
First posted
Dec 5, 2022
Start date
Jun 26, 2022
Primary completion
May 2023 (estimated)
Completion
Jul 2023 (estimated)
Last update
Dec 5, 2022

Study contacts

Merve Erünal
Contact
erunalmm@gmail.com
+905544635942
Hatice Mert
Contact
hatice.mert@deu.edu.tr
+092324124786
Merve Erünal
principal investigator · Dokuz Eylul University Faculty of Nursing
Hatice Mert
principal investigator · Dokuz Eylul University Faculty of Nursing

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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