Effect of Education on Disease Management to Women With Rheumatoid Arthritis on the Quality of Life and Levels of Anxiety and Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month
研究概览
简要总结
This randomized controlled study aimed to determine the effect of education on disease management on the quality of life, and anxiety and depression levels of women with Rheumatoid Arthritis.
The hypotheses of the current study are as below:
H0: Education on disease management in women with Rheumatoid Arthritis does not affect the quality of life and anxiety and depression levels.
H1: Education on disease management in women with Rheumatoid Arthritis affects the quality of life and anxiety and depression levels.
Patients and Methods: The study was conducted with 66 women with Rheumatoid Arthritis (32 intervention, 34 control groups) at the rheumatology clinic and polyclinic of a university hospital between February and October 2019, in the city of Edirne, Turkey. Data were collected with "Patient Information Form", "Rheumatoid Arthritis Quality of Life Scale", "Health Assessment Questionnaire" and "Hospital Anxiety Depression Scale".
详细描述
Study design and participants This pretest and posttest prospective study was conducted as randomized controlled between February 2019 and October 2019 in the outpatient and inpatient clinics of the Department of Rheumatology of a university hospital in Edirne, Turkey.
Two study groups, control (n = 40) and intervention (n = 40) were randomized controlled groups with 80% power analysis and 95% confidence interval. A single-blind technique was used to eliminate any bias. The patients were not informed of the group to which they belonged. The patients were selected using a simple random sampling method and divided into intervention and control groups using the Research Randomizer program. In the intervention group, 40 women with RA were interviewed at baseline (first interview). In the 3rd month (last interview), eight patients were excluded for the following reasons: four did not wish to continue the study, three could not be reached, and one patient did not complete the forms. Therefore, 32 women with RA were finally included in the intervention group. In the control group, 40 patients were interviewed at baseline. In the 3rd month (last interview), seven patients were excluded for the following reasons: four patients did not wish to continue the study and three patients could not be reached. Therefore, 34 women with RA were finally included in the control group. The study included a total of 66 women with RA, including intervention (n= 32) and control (n= 34) groups. Flow chart of data collection for women with RA is presented Figure 1.
Data collection tools Data were collected by The Patient Information Form, Rheumatoid Arthritis Quality of Life Scale, the Health Assessment Questionnaire, and the Hospital Anxiety Depression Scale.
Patient Information Form: Our study was developed by researchers in line with a literature review on the subject. (Bozbas & Gurer, 2018; Fall et al., 2013; Moghadam et al., 2018; Neto et al., 2009). The form consisted of eight questions about sociodemographic characteristics (age, marital status, education, etc.), clinical diagnosis, treatment of RA, concomitant chronic disease, and deformity affected by arthritis.
Rheumatoid Arthritis Patient Education Booklet: The content of the booklet was prepared by researchers in line with the literature. (arthritis.org; Moghadam et al., 2018; nras.org.uk; Rahim & Cheng, 2018). The education topics included description, symptoms, and signs of RA, diagnostic methods, treatment choices, information on medications, RA in pregnancy, disease management information, nutritional recommendations, emotional health, and support in daily living.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •To be female
- •18 years of age and older
- •Diagnosed with Rheumatoid Arthritis who reached the 2010 American College of Rheumatology (ACR) criterion
- •Had a disease period of at least 6 months
排除标准
- •Other serious and chronic mental disorders
- •Communication difficulties
- •Illiteracy
结局指标
主要结局
Change from baseline Rheumatoid Arthritis Quality of Life Questionnaire in the third month
时间窗: Patients' quality of life assess at baseline and in the third month.
The questionnaire consists of 30 questions, each with a score of "yes" = 1 or "no" = 0. The scores ranged from 0 to 30, with high scores showing poor quality of life.
次要结局
- Change from baseline Hospital Anxiety and Depression Scale (HADS) in the third month(Patients' HADS scores assess at baseline and in the third month.)
- Change from baseline Stanford Health Assessment Questionnaire (HAQ) in the third month(Patients' HAQ score assess at baseline and the third month.)
研究者
Irem Yildiz Cilengiroglu
Principal Investigator
Trakya University
