The Danish Center for Expertise in Rheumatology, Danish Hospital for Rheumatic Diseases, University Hospital of Southern Denmark Faculty of Health Sciences, Soenderborg, Denmark
Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
BMJ Open. 2024 Nov 27;14(11):e089050. doi: 10.1136/bmjopen-2024-089050.
Among people with chronic inflammatory arthritis (IA), up to 40% lose their job in the first few years after diagnosis of this condition and are hence at high risk of being permanently excluded from the labour market. Therefore, we developed a new context-specific vocational rehabilitation (VR) for people with IA. This 6 month VR (WORK-ON) includes the following: (1) an initial assessment and goal setting by a coordinating occupational therapist, who supports cooperation and coordination between relevant partners and navigation across primary and secondary care, (2) four group sessions with peers and (3) individual sessions with a social worker, nurse or physiotherapist. The objective of this trial is to test the overall efficacy of WORK-ON as an add-on to usual care and compare it with usual care provided to a control group.
A randomised controlled trial has been planned. Patients with IA, aged at least 18 years and experiencing job insecurity will be randomised to one of two groups: (1) the intervention group receiving WORK-ON VR as an add-on to usual care and (2) the control group receiving usual care. The primary outcome is the difference in work ability 12 months after baseline, which will be measured using the Work Ability Index single item. The key secondary outcome measures are absenteeism, presenteeism, overall work impairment, activity impairment and job loss measured at baseline and at 6, 12, 18 and 30 month follow-up. Secondary outcome measures are quality of life, mental well-being, fatigue, sleep, physical activity, occupational balance and pain, which will be measured at baseline and at 6 and 12 month follow-up.
The Regional Committees on Health Research Ethics in Southern Denmark waived the requirement for a formal approval (Journal number S-20232000-3). The participants will provide informed consent prior to participating in the trial.
NCT06299917.
在患有慢性炎症性关节炎（IA）的人群中，多达 40%的人在确诊后的头几年内失业，因此他们面临着被永久排除在劳动力市场之外的高风险。因此，我们为患有 IA 的人群开发了一种新的特定于情境的职业康复（VR）。这项为期 6 个月的 VR（WORK-ON）包括以下内容：（1）由协调职业治疗师进行初始评估和目标设定，该治疗师支持相关合作伙伴之间的合作和协调，并在初级和二级保健之间进行导航；（2）与同龄人进行四次小组会议；（3）与社会工作者、护士或物理治疗师进行个别会议。这项试验的目的是测试 WORK-ON 作为附加治疗对常规护理的整体疗效，并将其与对照组接受的常规护理进行比较。
计划进行一项随机对照试验。患有 IA、年龄至少 18 岁且面临工作不稳定的患者将被随机分配到以下两组之一：（1）干预组接受 WORK-ON VR 作为常规护理的附加治疗；（2）对照组接受常规护理。主要结局是基线后 12 个月时工作能力的差异，将使用工作能力指数单项来衡量。主要次要结局测量指标包括缺勤、工作效率低下、整体工作障碍、活动障碍和工作流失，这些指标将在基线和 6、12、18 和 30 个月随访时进行测量。次要结局测量指标包括生活质量、心理健康、疲劳、睡眠、身体活动、职业平衡和疼痛，这些指标将在基线和 6 个月和 12 个月随访时进行测量。
南丹麦地区健康研究伦理委员会豁免了正式批准的要求（期刊号 S-20232000-3）。参与者将在参与试验前提供知情同意。
NCT06299917。
