Education and Counseling Program on Patients With CIEDs and Low HL

NCT05636956 | Unknown

• 1 other identifier: 2018/16-34
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• Baseline knowledge level

  CIEDs knowledge scale score of patients

  Before education

• Change in knowledge level

  CIEDs knowledge scale score of patients

  At first month after education

• Change in knowledge level

  CIEDs knowledge scale score of patients

  At third month after education

• Change in knowledge level

  CIEDs knowledge scale score of patients

  At sixth month after education

• Baseline daily life activities

  Duke Activity Index score of patients

  Before education

• Change in daily life activities

  Duke Activity Index score of patients

  At first month after education

• Change in daily life activities

  Duke Activity Index score of patients

  At third month after education

• Change in daily life activities

  Duke Activity Index score of patients

  At sixth month after education

• Baseline health literacy level

  Health Literacy Survey European Questionnaire 16 score of patients

  Before education

• Change in health literacy level

  Health Literacy Survey European Questionnaire 16 score of patients

  At first month after education

• Change in health literacy level

  Health Literacy Survey European Questionnaire 16 score of patients

  At third month after education

• Change in health literacy level

  Health Literacy Survey European Questionnaire 16 score of patients

  At sixth month after education

Study Arms (2)

Patients who receive education and counseling program

EXPERIMENTAL

Patients with CIEDs and low health literacy received education and counseling program by researchers.

Other: Education and Counseling Program

Patients who receive clinical routine care

NO INTERVENTION

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

Interventions

Education and Counseling Program OTHER

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.

Patients who receive education and counseling program

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Merve Erunal

Balçova, İzmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac; Heart Failure; Behavior

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Merve Erünal

  Dokuz Eylul University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

• Hatice Mert

  Dokuz Eylul University Faculty of Nursing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Erünal

CONTACT

+905544635942; erunalmm@gmail.com

Hatice Mert

CONTACT

+092324124786; hatice.mert@deu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, MSc., PhD(c).

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: December 5, 2022
• Study Start: June 26, 2022
• Primary Completion: May 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11

Locations

TU (1)