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Study protocol of the Restore4Stroke self-management study: a multicenter randomized controlled trial in stroke patients and their partners

Authors

  • Nienke S. Tielemans,

    1. Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands
    2. Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
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  • Johanna M. A. Visser-Meily,

    1. Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
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  • Vera P. M. Schepers,

    1. Brain Center Rudolf Magnus and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht and De Hoogstraat Rehabilitation, Utrecht, The Netherlands
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  • Marcel W. M. Post,

    1. Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands
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  • Derick T. Wade,

    1. Oxford Centre for Enablement, Nuffield Orthopaedic Centre, Oxford, UK
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  • Caroline M. van Heugten

    Corresponding author
    1. Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University Medical Centre, Maastricht, The Netherlands
    2. Faculty of Psychology and Neurosciences, Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, The Netherlands
    • Correspondence: Caroline van Heugten*, Department of Psychiatry and Neuropsychology, Faculty of Health, Medicine and Life Sciences, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands.

      E-mail: c.vanheugten@maastrichtuniversity.nl

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  • Conflict of interest: The authors declare that they have no conflict of interest.
  • Trial registration: This study is registered in the Dutch Trial Register as NTR3051.
  • Funding: Restore4Stroke is supported by the Dutch VSBFonds (#89000004) and the Dutch Heart Foundation, and co-ordinated by ZonMW (Dutch Organization for Health Research and Development).

Abstract

Rationale

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.

Aim

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.

Design

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.

Study outcomes

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).

Discussion

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.

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