Education and Counseling Program on Patients With CIEDs and Low HL

Dokuz Eylül University (DEU)

Status: Enrolling

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

Treatments: Other: Education and Counseling Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05636956

2018/16-34

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Patients who receive education and counseling program

Experimental group

Description:

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

Treatment:

Other: Education and Counseling Program

Patients who receive clinical routine care

No Intervention group

Description:

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