Examining the Effects of Person-centered Lifestyle Intervention in Individuals With Rheumatoid Arthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measurement
研究概览
简要总结
It is aimed to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with rheumatoid arthritis.
详细描述
Rheumatoid arthritis (RA) is defined as a chronic, inflammatory autoimmune disease that can damage both joints and non-articular organs, including the heart, kidneys, lungs, digestive system, eyes, skin, and nervous system.
Management of RA requires a multidisciplinary approach, as common risk factors for RA include both modifiable lifestyle-related variables and non-modifiable traits such as genetics and gender. Although there is no definitive cure, it is necessary to optimize physical, emotional, and social health in order to minimize the impact of the disease. At this point, self-management interventions come to the fore.
Since many areas of life are affected in individuals with RA, it is seen that there is a need for combined treatments that address the individual holistically, as suggested by EULAR. Lifestyle intervention is a combined approach that encourages individuals to change their lifestyles by increasing participation in meaningful readings. There is strong evidence in the literature that Lifestyle intervention is an effective approach to managing the symptoms of many chronic diseases.
The number of studies involving lifestyle interventions in individuals with RA, whose importance is emphasized in the literature, is limited. Therefore, our study was planned to examine the effects of person-centered lifestyle intervention on occupational performance, general health status, and quality of life in individuals with RA. Hypotheses:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being diagnosed with RA between the ages of 18-65 and meeting the ACR/EULAR diagnostic criteria
- •Patients with low to moderate disease activity (DAS28 ≤5.1)
- •No pharmacological treatment changes for RA in the last 3 months
- •Have not had any surgery in the last 6 months
- •Understand and cooperate with testing guidelines
- •to be literate
排除标准
- •Having any musculoskeletal disease, neurological disease, and/or visual and auditory impairment other than RA
- •Pregnancy
研究组 & 干预措施
Person-centered lifestyle intervention group
Intervention group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.
Person-centered lifestyle intervention in individuals with rheumatoid arthritis is planned as 2 sessions per week, for a total of 4 weeks.
干预措施: person-centered lifestyle intervention (Behavioral)
Control group
Control group: Volunteers who were diagnosed with RA by a rheumatologist according to the 2010 criteria of the American College of Rheumatology (ACR)/European Rheumatology Association (ACR/EULAR) will be included in the study.
For the control group, they will be called twice a week for 4 weeks and inquired about their general condition.
干预措施: person-centered lifestyle intervention (Behavioral)
结局指标
主要结局
Canadian Occupational Performance Measurement
时间窗: change from baseline score at the end of 4 weeks and 6 months
COPM is a standardized measurement tool that reflects the change in an individual's personal perception of activity performance and satisfaction over a period of time. It is designed to identify the activity performance problems of the individual, to give priority to these areas and to develop person-centered practice. In this assessment scale, activity performance problems faced by the person in the areas of self-care, productivity, play-free time are recorded with a semi-structured interview method. Among these areas, the person is asked to select 5 problems that he prioritizes and to rate each problem area between 1 and 10 points. A higher score on this rating indicates greater performance and satisfaction. The calculation is made by dividing the total performance and satisfaction score by the number of selected activities.
次要结局
- Rheumatoid Arthritis Quality of Life Scale(change from baseline score at the end of 4 weeks and 6 months)
- The Bristol Rheumatoid Arthritis Fatigue Multidimensional Questionnaire (BRAF-MDQ)(change from baseline score at the end of 4 weeks and 6 months)
- Health Assessment Questionnaire (HAQ)(change from baseline score at the end of 4 weeks and 6 months)
- General Self-Efficacy Scale(change from baseline score at the end of 4 weeks and 6 months)
- The DAS 28 Disease Activity scale(change from baseline score at the end of 4 weeks and 6 months)
- Hospital Anxiety and Depression Scale (HADS)(change from baseline score at the end of 4 weeks and 6 months)
研究者
SULTAN BASTURK
professional
Hacettepe University