"Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke.

ABSTRACT

BACKGROUND: Elderly people represent the majority of stroke cases worldwide. Post-stroke sequelae frequently lead to a more isolated life. Restricted social relations render older individuals with stroke a vulnerable group, especially in terms of social reintegration. Reintegration into the community after a stroke largely depends on support from the family. However, close relatives are at risk of becoming overburdened. The aim of this study is to investigate the effect of a novel self-management intervention to support elderly people after stroke. METHODS/DESIGN: Randomized controlled trial. Two weeks before discharge from a rehabilitation hospital/center, individuals with stroke aged > 65 years will be randomized either to a group receiving conventional neurorehabilitation (control) or to an additional novel self-management intervention. In the intervention group, patients with stroke will be offered eight self-management sessions of 45-60 min duration by a physiotherapist or an occupational therapist during a period of nine months after discharge. Inclusion will continue until at least 35 individuals in each group have been recruited. Study outcome measurements Stroke Self-efficacy Questionnaire, a short version of Stroke Specific Quality of Life Scale, Impact on Participation and Autonomy and Caregiver Burden Scale. Furthermore, physical activity will be assessed using accelerometers. All outcomes except "impact on participation" and "autonomy" will be assessed at baseline, three months, and nine months after discharge. Impact on participation and autonomy will be assessed at three and nine months after discharge. Patient, informal caregiver, and therapist satisfaction will be examined by way of questionnaires and interviews. DISCUSSION: Self-management interventions are promising strategies for rehabilitation, potentially increasing self-efficacy, quality of life, as well as participation and autonomy. The introduction of a novel self-management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke and quality of life and lessen the burden on relatives. This trial "Stroke - 65 Plus. Continued Active Life," will provide further evidence of self-management strategies to clinicians, patients, and health economists. TRIAL REGISTRATION ClinicalTrials.gov, NCT03183960 . Registered on 12 June 2017.