The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Dokuz Eylul University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Baseline health literacy level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- 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
- •Not literate
- •having vision or hearing problem
- •having psychiatric and cognitive impairment
Outcomes
Primary Outcomes
Baseline health literacy level
Time Frame: Before education
Health Literacy Survey European Questionnaire 16 score of patients
Change in daily life activities
Time Frame: At sixth month after education
Duke Activity Index score of patients
Baseline knowledge level
Time Frame: Before education
CIEDs knowledge scale score of patients
Change in health literacy level
Time Frame: At sixth month after education
Health Literacy Survey European Questionnaire 16 score of patients
Change in knowledge level
Time Frame: At sixth month after education
CIEDs knowledge scale score of patients
Baseline daily life activities
Time Frame: Before education
Duke Activity Index score of patients
Secondary Outcomes
No secondary outcomes reported
Investigators
Merve Erunal
Research Assistant, MSc., PhD(c).
Dokuz Eylul University