The Effect of Education and Counseling Program on Patients With Cardiac Implantable Electronic Devices and Low Health Literacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Baseline health literacy level
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Not literate
- •having vision or hearing problem
- •having psychiatric and cognitive impairment
结局指标
主要结局
Baseline health literacy level
时间窗: Before education
Health Literacy Survey European Questionnaire 16 score of patients
Change in daily life activities
时间窗: At sixth month after education
Duke Activity Index score of patients
Baseline knowledge level
时间窗: Before education
CIEDs knowledge scale score of patients
Change in health literacy level
时间窗: At sixth month after education
Health Literacy Survey European Questionnaire 16 score of patients
Change in knowledge level
时间窗: At sixth month after education
CIEDs knowledge scale score of patients
Baseline daily life activities
时间窗: Before education
Duke Activity Index score of patients
次要结局
未报告次要终点
研究者
Merve Erunal
Research Assistant, MSc., PhD(c).
Dokuz Eylul University