“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

“Stroke - 65 plus. Continued active life.” A randomized controlled trial of a self-management neurorehabilitation intervention for elderly people after stroke

Post-stroke sequelae among elderly often lead to a more inactive life while carrying a risk of overburdening close relatives. The objective of the present study was to determine if a novel self-management neuro-rehabilitation intervention added to usual treatment for people with stroke over the age of 65 years improved their self-efficacy. This randomised controlled trial included participants two weeks before discharge from subacute rehabilitation. All participants received usual treatment. The intervention entailed an add-on of six to eight self-management sessions lasting 45–60 min within a period of nine months after discharge. This novel neuro-rehabilitation intervention focused on promoting growth, development and self-efficacy by facilitating the participants’ self-management strategies regarding their activities and social network. All participants were assessed at baseline, three months and nine months after discharge. The primary outcome was self-efficacy measured by the Stroke Self-Efficacy Questionnaire. Sixty-nine individuals with stroke aged > 65 years were randomised. Their mean(SD) age was 76(6) years; 32 (46%) were female. No significant difference was found between the groups at baseline. Improvement recorded in the intervention group did not significantly differ from that of the control group with regard to primary outcome or secondary outcomes. This novel self-management intervention had no significant effect measured by the primary outcome self-efficacy or quality of life. Furthermore, no impact was observed on participation and autonomy compared with usual treatment. Clinical trial registration—URL: ClinicalTrials.gov, NCT03183960. Registered on 12 June 2017. The present study testing a novel self-management neuro-rehabilitation intervention for people with stroke aged more than 65 years failed to improve self-efficacy, quality of life, and impact on participation and autonomy.Post hoc analyzes showed a lower caregiver burden at three and nine months in the intervention group as compared to the control group.The approach of perceiving the stroke individual and the informal caregiver as one unit (dyad), involving both in decisions regarding everyday activities and roles in everyday life especially within their shared part of life, appears important and warrants further development. The present study testing a novel self-management neuro-rehabilitation intervention for people with stroke aged more than 65 years failed to improve self-efficacy, quality of life, and impact on participation and autonomy. Post hoc analyzes showed a lower caregiver burden at three and nine months in the intervention group as compared to the control group. The approach of perceiving the stroke individual and the informal caregiver as one unit (dyad), involving both in decisions regarding everyday activities and roles in everyday life especially within their shared part of life, appears important and warrants further development.</p