Testing the Effectiveness of Fatigue and Activity Management in Work (FAME-W) Self-management Intervention for Individuals With Inflammatory Arthritis
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Work Role Functioning Questionnaire
研究概览
简要总结
Many individuals with Inflammatory Arthritis (IA) experience symptoms of pain and fatigue which interfere with work. Over 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity. Loss of ability to continue paid employment results in physical, emotional and financial hardship for individuals with IA and has societal and economic implications. Previous research has identified pain and fatigue as dominant symptoms that interfere with work capacity and therefore interventions are required to reduce the impact of these symptoms on work activities. The purpose of this study therefore is to test the effectiveness of a 4-week Fatigue and Activity Management Education for Work intervention. The study will use a mixed methods design. A randomized control trial will test the effectiveness of the intervention and a qualitative process evaluation with explore acceptability and participants' experiences of the intervention. Individuals with IA, of working age, will be recruited in Rheumatology outpatient departments of three hospitals. Study participants will be randomly assigned to a four-week online self-management intervention or a self-guided symptom management workbook. Study measures consist of self-report questionnaires related to work and symptom management. All participants will also be invited to an interview to discuss their experience of participating in the study.
详细描述
Rheumatic diseases (RD) include over 100 different types of arthritis, the most frequently occurring being Rheumatoid Arthritis, Osteoarthritis, Scleroderma, Systemic Lupus erythmatosus and ankylsoing Spondylitis. However, Inflammatory Arthritis (IA) are one of the most common causes of work disability and despite improvements in medical management of IA, up to 50% of people with IA report workplace difficulties resulting in sick leave, absenteeism and reduced productivity.
This study builds on existing research investigating the impact of IA on work performance of individuals. These earlier studies examined how symptoms of fatigue, pain and stress impact on work capacity of individuals with IA. Based on the findings of these studies a self-management program, FAtigue Management Education for Work (FAME-W) was designed to reduce the impact of fatigue, pain and stress on work performance of individuals with IA. Pilot testing of FAME-W, with a non-experimental design, showed improvements in fatigue, work performance, pain and mood following participation in FAME-W. The proposed study will build on this research by testing the effectiveness of FAME-W as a work-focused self-management intervention to increase work performance of individuals with IA.
Project Design and Methodology
Study Aim
The purpose of this study is to test the effectiveness and acceptability of FAME-W to manage the physical, mental and social demands of work of individuals with IA.
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
- None
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
- 否
入选标准
- •Clinical diagnosis of Inflammatory Arthritis,
- •In full-time or part-time employment
- •Must be able to provide informed consent,
- •Must be able to participate in a four-week group-based self-management intervention
- •Must have access to an electronic device and stable internet access
排除标准
- 未提供
研究组 & 干预措施
Arm 1: FAME-W intervention
Four-week self-management education programme
干预措施: FAME-W self-management intervention (Behavioral)
Arm 2: FAME-W handbook
Self-guided FAME-W handbook
干预措施: FAME-W Handbook (Behavioral)
结局指标
主要结局
Work Role Functioning Questionnaire
时间窗: Three months
Work Role Functioning questionnaire is a 27-self-report questionnaire that measures an individual's ability to meet demands of five categories of work: scheduling, output, psychical, mental and social demands. All 27 items are scored on a five point scale, with a score of four given for the response 'difficult none of the time' and a score of zero representing 'difficult all of the time'. Each of the five sub-scales are scored separately. A score is established by adding the response of each item, calculating the average and multiplying this by 25 to achieve an overall percentage. The overall percent can range from 0% (difficult all of the time), to 100% (never difficult) meeting the demands of the job.
次要结局
- The Arthritis Impact Measurement Scale(Three months)
- Euro QoL 5 Dimensions -5 levels (5D-5L)(Three months)
- Multidimensional Fatigue Inventory(Three months)
- Arthritis Work Spillover(Three months)
- Hospital Anxiety and Depression scale (HADS)(Three months)
- The Stanford Arthritis Self-Efficacy Scale Short Form(Three months)
- The Short Form McGill Pain Questionnaire(Three months)
研究者
Deirdre Connolly
Professor Deirdre Connolly
University of Dublin, Trinity College