title: Study protocol of the Restore4Stroke self-management study: a multicenter randomized controlled trial in stroke patients and their partners.
abstract: BACKGROUND
  Many stroke patients and their partners report long-term negative consequences of stroke on their health-related quality of life. Adequate self-management abilities may help manage the consequences of the stroke, but it is unknown what specific intervention might be effective to enhance self-management abilities of stroke patients and their partners.
  
  
  OBJECTIVE
  The study aims to investigate the effectiveness of a 10-week group self-management intervention addressing proactive coping strategies compared with a group education intervention in stroke patients and their partners.
  
  
  METHODS
  The study is a multicenter randomized controlled trial. A total of 106 stroke patients with, if applicable, their partners are randomly assigned to the self-management intervention or the education intervention within each of the 10 participating hospitals and rehabilitation centers. The main inclusion criteria are a symptomatic stroke at least six-weeks ago, living at home, and reporting at least two participation restrictions on the Utrecht Scale for Evaluation of Rehabilitation-Participation's restriction scale. Measurements are performed at baseline, immediately after intervention, three-months, and nine-months postintervention.
  
  
  RESULTS
  Primary outcome measures are stroke patients' and partners' proactive coping competencies (Proactive Competence Inventory) and societal participation (Utrecht Scale for Evaluation of Rehabilitation-Participation's restriction scale).
  
  
  CONCLUSIONS
  If effective, the results of this study will enable stroke patients and their partners to deal better with the lasting consequences of stroke. In the context of the growing number of people returning home after stroke, a large number of people may profit from this intervention.
authors.affiliation: Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands; Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands.
authors.forename: Nienke S
authors.initials: NS
authors.lastname: Tielemans
authors.forename: Johanna M A
authors.initials: JM
authors.lastname: Visser-Meily
authors.forename: Vera P M
authors.initials: VP
authors.lastname: Schepers
authors.forename: Marcel W M
authors.initials: MW
authors.lastname: Post
authors.forename: Derick T
authors.initials: DT
authors.lastname: Wade
authors.forename: Caroline M
authors.initials: CM
authors.lastname: van Heugten
mesh_terms: D000223:Adaptation, Psychological; D017028:Caregivers / Q000523:psychology*; D002985:Clinical Protocols; D006801:Humans; D009426:Netherlands; D010353:Patient Education as Topic / Q000379:methods; D018579:Patient Selection; D011788:Quality of Life; D018401:Sample Size; D012648:Self Care / Q000379:methods* / Q000523:psychology; D020521:Stroke / Q000523:psychology*; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome
keywords: clinical trial; health-related quality of life; intervention; proactive coping; stroke