Self-management Nursing Intervention for Women With Rheumatoid Arthritis: A Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Self-management behaviors
研究概览
简要总结
Introduction. Chronic autoimmune diseases are catalogued as catastrophic conditions that generate a negative impact on the health and well-being of the affected person. In this particular case, rheumatoid arthritis (RA) is its main representative, which is a predominant disease in women, affecting not only the musculoskeletal system but in general, all dimensions of the human being and generating great costs for health systems. Adaptation to living with the disease requires the individual to develop capacities for a positive management of the condition, and in this sense, the development of self-management behaviors becomes a crucial element. Method. The investigators propose a two-arm pragmatic randomized clinical trial with pre- and post-intervention measures, to evaluate the effect of the Chronic Disease Selfmanagement Program (CDSMP) on the increase in the levels of self-efficacy, self-management and health-related quality of life of women with RA who are attended by outpatient rheumatology consultation in a health institution in Bogota compared to usual care. Results. A description will be made of the sociodemographic and clinical variables present in you together with the measurement of the variables of health-related quality of life through the Quality Of Life-Rheumatoid Arthritis Scale-II (QOLRA-II); self-efficacy with the specific scale of self-efficacy in arthritis; and self-management behaviors by means of the scale of self-management in the disease. The measurement for the intervention group will be performed before and after the implementation of the program and for the control group an initial measurement and another one after six weeks. Discussion. The implementation of the CDSMP could generate a positive effect on the variables of self-management, self-efficacy and health-related quality of life in women with RA who are attended by outpatient consultation in a health institution in Bogota compared to usual care.
详细描述
Statement of the problem Inflammatory rheumatic diseases, as chronic degenerative diseases, represent a high expense for the General Social Security Health System (SGSSS) reflected in the costs of care and the affectation in the personal, labor, social and family spheres that cause a deterioration in the quality of life related to the health of the individual.
The main representative of this group is RA, considered as a chronic and disabling systemic disease affecting joints, connective tissue, muscles, tendons and fibrous tissue. By causing pain and deformity, it is one of the main causes of absenteeism and premature retirement from work in the world.
However, the general age of onset is in adulthood. In the interval between 55 and 59 years of age, about 50% of people suffering from this condition, after 10 years, have lost their ability to work or are unable to maintain a full-time job.
Looking at Colombia, figures reveal that 2.2% of the general population suffers from RA. Specifically, for the year 2022, a total of 118,497 cases were reported, of which 5,115 were incidents with a percentage increase of 41.53 % compared to the previous period and, of these, 81.52 % are women, with a female-to-male ratio of 4.41 to 1. Regarding the situation observed in Bogotá, the High-Cost Account (CAC) states that this is one of the regions with the highest number of cases reported by the territorial entities: 28,012 for the year 2022.
Because of the personal, physical, occupational, family and social impact it produces on the health and well-being of the affected population, RA is classified as a ruinous, catastrophic, progressive, high-cost disease of public health interest. Specifically, its presence in the female population represents a source of low levels of health-related quality of life (HRQoL).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In order to guarantee the objectivity and impartiality of the research team, randomization will be accompanied by blinding. A single-blind trial is proposed in which the participants during the conduct of the study will be unaware of their assignment to the experimental or control groups; likewise, the research assistants who perform the pre and post measurement will be unaware of their assignment to the groups; there will be specific assistants for the pre measurement and specific assistants for the post measurement with each group. Candidates will be invited to participate in the study, explaining to them that it is a randomized study in which they may be assigned to a specific intervention group, that their assignment will only be random, that neither the research team nor the treating health team will be able to interfere with their assignment and that this will be revealed to them once the study is completed.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •This study examined women over the age of 18 who were treated at rheumatology outpatient clinics at a health center in Bogotá and had a confirmed diagnosis of rheumatoid arthritis according to the 2010 EULAR/ACR classification criteria.
排除标准
- •Women with RA with a comorbid acute process (another or other chronic diseases that the person suffers from and at the time of being identified, are in the exacerbation or crisis phase).
- •Women with RA who present cognitive impairment that prevents them from participating in the program or answering the questionnaires due to cognitive impossibility to understand them.
结局指标
主要结局
Self-management behaviors
时间窗: 8 weeks
For self-management, participants are expected to achieve a high overall score on the self-management behaviors scale, with scores above 80 points. The scale consists of 12 items with three dimensions: adherence to treatment (7 items 3, 4, 5, 6, 7, 8 and 12); symptom management (3 items 9, 10 and 11) and knowledge (2 items 1 and 2). The answers to the 12 items of the instrument are structured on a scale of 0 to 8 points, the sum of the scores obtained in each item presents the global self-management, the higher the score, the higher the global self-management (0 to 96 points). To identify the specific score for each dimension, the sum of the items corresponding to each dimension (knowledge: maximum score 16 points; adherence: 56 points; and symptom management: 24 points) is added together.
次要结局
- Health-related quality of life(8 weeks)
- Perceived Self-efficacy,(8 weeks)