Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, PO Box 2040, 3000 CA, Rotterdam, the Netherlands.
BMC Neurol. 2013 Jun 27;13:67. doi: 10.1186/1471-2377-13-67.
Coping style is one of the determinants of health-related quality of life after stroke. Stroke patients make less use of active problem-oriented coping styles than other brain damaged patients. Coping styles can be influenced by means of intervention. The primary aim of this study is to investigate if Problem Solving Therapy is an effective group intervention for improving coping style and health-related quality of life in stroke patients. The secondary aim is to determine the effect of Problem Solving Therapy on depression, social participation, health care consumption, and to determine the cost-effectiveness of the intervention.
METHODS/DESIGN: We strive to include 200 stroke patients in the outpatient phase of rehabilitation treatment, using a multicenter pragmatic randomized controlled trial with one year follow-up. Patients in the intervention group will receive Problem Solving Therapy in addition to the standard rehabilitation program. The intervention will be provided in an open group design, with a continuous flow of patients. Primary outcome measures are coping style and health-related quality of life. Secondary outcome measures are depression, social participation, health care consumption, and the cost-effectiveness of the intervention.
We designed our study as close to the implementation in practice as possible, using a pragmatic randomized trial and open group design, to represent a realistic estimate of the effectiveness of the intervention. If effective, Problem Solving Therapy is an inexpensive, deliverable and sustainable group intervention for stroke rehabilitation programs.
Nederlands Trial Register, NTR2509.
应对方式是影响卒中后健康相关生活质量的决定因素之一。与其他脑损伤患者相比，卒中患者较少采用积极的问题导向应对方式。应对方式可以通过干预来影响。本研究的主要目的是调查问题解决疗法是否是一种有效的团体干预措施，以改善卒中患者的应对方式和健康相关生活质量。次要目的是确定问题解决疗法对抑郁、社会参与、医疗保健消费的影响，并确定干预措施的成本效益。
方法/设计：我们努力在康复治疗的门诊阶段纳入 200 名卒中患者，采用多中心实用随机对照试验，随访 1 年。干预组患者除了接受标准康复方案外，还将接受问题解决疗法。干预将采用开放组设计，患者持续入组。主要结局指标是应对方式和健康相关生活质量。次要结局指标是抑郁、社会参与、医疗保健消费以及干预措施的成本效益。
我们设计的研究尽可能接近实践中的实施情况，采用实用随机试验和开放组设计，以对干预措施的有效性进行现实估计。如果有效，问题解决疗法是一种廉价、可提供和可持续的卒中康复计划团体干预措施。
荷兰临床试验注册中心，NTR2509。
