Medical In-Patient Rehabilitation in Rheumatoid Arthritis: Acceptance and Outcomes in Insurants of Compulsory Health Insurances and Statutory Pension Insurances (VERA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- work incapacity (incidence, duration)
研究概览
简要总结
The randomised controlled trial explores the efficacy of a counselling interview on an multidisciplinary multimodal intervention to ameliorate the somatic, mental and social medical progress of rheumatoid arthritis in gainfully employed insurants of compulsory health insurances and statutory pension insurances . Additionally, the feasibility to recruit a study population via databases of compulsory health insurances is examined.
详细描述
Rheumatoid arthritis is the most prevalent inflammatory rheumatic disease. Limited participation of the individual patient accumulates with large amounts of indirect costs for society: About 40 % of the affected patients have to quit their jobs within the first three to four years after disease onset. Nevertheless, the German health care system still seems to lack an adequate supply, particularly in case of medical rehabilitation in early stages of disease. International clinical trials, reviews amd evidence-based guidelines emphasize the importance of an early multimodal multidisciplinary team care as in Germany provided by specialised clinics through three-week in-patient medical rehabilitation programs. The available study explores the efficacy of a counselling interview on an medical in-patient rehabilitation in a randomised controlled design. Exclusively, gainfully employed insurants of compulsory health insurances and statutory pension insurances are included in the study.
Secondary, to avoid the problem of a selection bias caused by recruitment via clinics or doctors, the RCT tests the possibility to recruit potential participants by data of the co-operating health insurances on RA-specific diagnoses of work incapacity, hospital discharge diagnoses, and medical prescriptions within the past 24 months.
Detailed process:
- Recruitment of a potential study population via health insurance data (defined search criteria: ICD-10 diagnoses M05/06/13/79 in case of work disability/hospital discharge, RA-specific medical prescriptions within the past 24 months)
- screening questionnaire to verify in-/exclusion criteria
- selection of eligible insurants (RA-criteria of American College of Rheumatology, clinical expert)
- baseline measurement (e.g. SF-36, RAQoL, FFbH-P, SPE)
- external stratified block by block randomization: intervention group (3- week medical in-patient rehabilitation) vs. control group (usual care)
- follow-up measurement (12 months after baseline)
- data transfer of health insurances and pension insurances
Comparison:
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
- 20 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid arthritis / psoriatic arthritis (expert decision, ACR criteria)
- •Insurant of co-operating health insurance and pension insurance
- •Gainfully employed
- •Eligible to receive a medical in-patient rehabilitation
排除标准
- •Polyarthritis, inflammatory intestinal diseases and diseases of connective tissue
- •Currently work disabled
- •Not able / not willing to co-operate
- •Medical in-patient rehabilitation within past 48 months
研究组 & 干预措施
IG
intervention group, receives counselling on medical inpatient rehabilitation by statutory health insurance, is intended to apply for a 3-wek medical inpatient rehabilitation at the co-operating clinic (Bad Bramstedt)
干预措施: Counselling and 3-week medical in-patient rehabilitation (Procedure)
KG
control group, receives usual care
结局指标
主要结局
work incapacity (incidence, duration)
时间窗: baseline, 12 months follow-up
次要结局
- general health status (SF-36)(baseline, 12 months follow-up)
- Functional capacity (FFbH-P)(baseline, 12 months follow-up)
- Quality of life (RAQoL)(baseline)
- Subjective prognosis of gainful employment (SPE-scale)(baseline, 12 months follow-up)
- Somatization (SCL-90-R)(baseline, 12 months follow-up)
- Depression(baseline, 12 months follow-up)