Effect of a Self-Management Intervention for Patients Newly Diagnosed With Inflammatory Arthritis: Study Protocol for a Randomized Controlled NISMA Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Primary outcome and endpoint
研究概览
简要总结
Background:
In patients newly diagnosed with inflammatory arthritis, a self-management intervention is anticipated to enhance self-management skills, thereby improving patient function, well-being, and survival. The primary objective of the trial is to investigate the short-term efficacy of the NISMA intervention and usual care, compared to usual care alone (control group), on self-management skills and techniques in patients newly diagnosed with inflammatory arthritis.
Method:
This study aims to test the efficacy of the "Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention" (NISMA) through a multicenter pragmatic randomized controlled trial (RCT). The trial will involve 130 patients newly diagnosed with IA from three Danish hospitals. Participants will be randomly assigned to either the NISMA intervention group or a control group receiving usual care. The NISMA intervention includes three mandatory individual sessions with a nurse, supplemented by two optional group sessions over 12 months.
Primary outcomes will be measured using the Health Education Impact Questionnaire (heiQ), focusing on the "skill and technique acquisition" domain. Secondary outcomes include other heiQ domains, quality of life, loneliness, physical function, pain intensity, pain, self-efficacy, anxiety and depression, fatigue, patient global assessment, disease activity, and medication adherence. Data will be collected at baseline, 12 months, and 18 months post-baseline.
Discussion:
This RCT will provide essential insights into the effectiveness of a targeted self-management intervention for patients newly diagnosed with IA. The NISMA intervention, developed following the Medical Research Council Framework for complex interventions, aims to improve self-management skills and overall QoL. By addressing the unique challenges faced by newly diagnosed patients, this study seeks to enhance the initial management of IA, aligning with the European Alliance of Associations for Rheumatology (EULAR) recommendations for self-management support. If successful, the NISMA intervention could represent a significant advancement in the non-pharmacological management of IA, offering a comprehensive, patient-centered approach that addresses both physical and psychological needs.
详细描述
Background:
Inflammatory arthritis (IA), including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), encompasses acute and chronic joint diseases characterized by joint pain, swelling, and tenderness due to inflammation. IA affects over 2% of the global population, with significant variability. It can occur at any age and affects both sexes, with an etiology involving genetic and lifestyle factors. IA primarily causes joint pain and stiffness but can also impact other connective tissues. Without adequate treatment, IA can lead to functional decline, irreversible joint damage, comorbidities, and increased mortality. Early treatment with disease-modifying anti-rheumatic drugs (DMARDs) improves outcomes, with about 60% of RA patients achieving long-term remission. However, symptoms may persist and fluctuate, causing ongoing physiological and psychological distress, impacting daily activities and quality of life (QoL), even in remission.
Newly diagnosed patients with IA face particular challenges, including regular blood tests, lifelong medication, side effects, pain, fatigue, sleep disturbances, and increased risk of comorbidities like depression and cardiovascular disease. They often experience changes in body image, family, work, and social life. A crucial but often lacking aspect of IA care is empowering patients with a thorough understanding of their condition and effective self-management skills. Studies show that newly diagnosed patients benefit from regular consultations and support from health professionals (HPs) to manage the physical, emotional, and social impacts of IA. Enhanced self-management, defined as the ability to manage symptoms, treatments, and lifestyle changes, can improve QoL in chronic illness patients. EULAR recommends incorporating self-management into daily rheumatology care, including patient education and key approaches like problem-solving and action planning. Despite this, no IA-specific self-management interventions focused on newly diagnosed patients exist.
Rationale:
To address this gap, the "Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention" (NISMA) was developed. Following the Medical Research Council (MRC) Framework [29,30] for developing and evaluating complex interventions, the researchers developed NISMA and tested its feasibility and fidelity. Feedback from patients and HPs led to adjustments in session duration, the number of sessions, flexible scheduling, recruitment strategies, and inclusion criteria for axSpA patients. Group sessions were made optional, and more emphasis was placed on certain behavior change techniques.
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 (Outcomes Assessor)
盲法说明
Due to the nature of the NISMA intervention blinding of participants is impossible. However, the outcome assessor will be blinded, and participants will be asked not to disclose their group to the assessor.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients will be included if they are adults aged 18 years or older with one of the following conditions:
- •Rheumatoid Arthritis (RA) with ICD-10 codes: M05.3, M05.9, M05.8, M06.9 diagnosed within the last 6 months
- •Psoriatic Arthritis (PsA) with ICD-10 codes: M073.A, M073.B diagnosed within the last 6 months
- •Axial Spondyloarthritis (axSpA) with ICD-10 codes: M45.9, M46.1, M46.8, M46.9, diagnosed within the last 12 months, and has initiated biological treatment
- •Patients with axSpA will have unique inclusion criteria due to NSAIDs being the first-line pharmacological treatment. For those effectively treated with NSAIDs and exercise, treatment is transitioned to their general practitioner. Therefore, only those who have initiated biological treatment will be included.
排除标准
- •Patients will be excluded if they:
- •have insufficient language skills to discuss the topics in the intervention in Danish
- •are receiving chemo-therapy treatment for malignancies
- •are pregnant
- •have severe mental illness.
研究组 & 干预措施
controlgroup
There are no established standards for identifying and addressing self-management needs in rheumatology outpatient consultations. Participants allocated to the control group will receive usual care, which consists of planned sessions with a rheumatologist and occasionally a nurse, a physiotherapist, and an occupational therapist. Those who started DMARDs of any type had an appointment with a nurse and a follow-up phone call. All participants will have the possibility to contact the outpatient clinic and talk to a nurse. Participants in the control group will be encouraged to maintain their usual daily routines and self-management practices until the follow-up assessment is conducted.
intervention group
Participants allocated to the intervention group will receive the NISMA Intervention in addition to usual care.
干预措施: Newly diagnosed with Inflammatory arthritis - a Self-MAnagement intervention (NISMA) (Behavioral)
结局指标
主要结局
Primary outcome and endpoint
时间窗: Baseline-end of intervention (12 months after baseline).
The primary outcome measure is self-management skills, assessed by the Health Education Impact Questionnaire (heiQ) - the skill and technique acquisition domain. (Higher score is better). The primary endpoint will be the difference in least squares means between groups, analyzed at 12 months from baseline.
次要结局
- Health Related Quality of Life(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Loneliness(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Self-management skills measured by the Health Education Impact Questionnaire (heiQ)(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Physical function(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Anxiety and depression(Baseline-end of intervention (12 months after baseline), and 24 months after baseline)
- Pain self-efficacy(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Pain Intensity(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
- Medication adherence(Baseline-end of intervention (12 months after baseline), and 24 months after baseline)
- Patient global(Baseline-end of intervention (12 months after baseline), and 24 months after baseline)
- Disease activity(Baseline-end of intervention (12 months after baseline), and 24 months after baseline)
- Fatigue(Baseline-end of intervention (12 months after baseline), and 24 months after baseline.)
研究者
Bente Appel Esbensen
Professor
Rigshospitalet, Denmark