Clinical trial NCT05636956: Education and Counseling Program on Patients With CIEDs and Low HL
Official title: The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmias, Cardiac
Heart Failure
Health Knowledge, Attitudes, Practice
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline knowledge level
timeFrame: Before education
measure: Change in knowledge level
timeFrame: At first month after education
measure: Change in knowledge level
timeFrame: At third month after education
measure: Change in knowledge level
timeFrame: At sixth month after education
measure: Baseline daily life activities
timeFrame: Before education
measure: Change in daily life activities
timeFrame: At first month after education
measure: Change in daily life activities
timeFrame: At third month after education
measure: Change in daily life activities
timeFrame: At sixth month after education
measure: Baseline health literacy level
timeFrame: Before education
measure: Change in health literacy level
timeFrame: At first month after education
measure: Change in health literacy level
timeFrame: At third month after education
measure: Change in health literacy level
timeFrame: At sixth month after education
Secondary outcomes:
Other outcomes:
Locations:
city: Balçova
country: Turkey
facility: Merve Erunal
state: İzmir
Study officials:
affiliation: Dokuz Eylul University Faculty of Nursing
name: Merve Erünal
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University Faculty of Nursing
name: Hatice Mert
role: PRINCIPAL_INVESTIGATOR
References: