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Abstract Background Worldwide, mild traumatic brain injury, synonymous with concussion, affects more than 30–50 million each year. The incidence of concussion in Denmark is estimated to be about 20,000 yearly. Although complete resolution normally occurs within a few weeks, up to a third develop persistent post-concussion symptoms (PPCS) beyond 3 months. Evidence for effective treatment strategies is scarce. The objective of this study is to evaluate the efficacy of the novel intervention GAIN Lite added to enhanced usual care (EUC) for adults with mild-to-moderate PPCS compared to EUC only. Methods An open-label, parallel-group, two-arm randomised controlled superiority trial (RCT) with 1:1 allocation ratio. Potential participants will be identified through the hospital’s Business Intelligence portal of the Central Denmark Region or referred by general practitioners within 2–4 months post-concussion. Participants with mild-to-moderate PPCS will be randomly assigned to either (1) EUC or (2) GAIN Lite added to EUC. GAIN Lite is characterised as a complex intervention and has been developed, feasibility-tested and process evaluated before effect evaluation in the RCT. GAIN Lite contains an initial remote interview, self-administrated e-learning videos and voluntary remote counselling with an allocated occupational- or physiotherapist. Sixty-six participants will be recruited to each group. Primary outcomes are mean changes in PPCS and limitations in daily life from baseline to 24 weeks after baseline. Discussion GAIN Lite is a low-intensity intervention for adults with mild-to-moderate PPCS. Offering a remote intervention may improve access to rehabilitation and prevent chronification for individuals with mild-to-moderate PPCS. Moreover, GAIN Lite will facilitate access to healthcare, especially for those with transportation barriers. Overall, GAIN Lite may provide an accessible, flexible and convenient way to receive treatment based on sound theories and previous evidence of effective interventions for adults with mild-to-moderate PPCS. Trial registration ClinicalTrials.gov NCT05233475. Registered on February 10, 2022.

Abstract Background A good portion of stroke patients in Western countries are over 65 of age. Because of sequelae, they often lead more isolated lives after the stroke. In terms of social reintegration, this group of patients is especially vulnerable. Reintegration into the community post-stroke greatly depends on support from family. However, the stroke individual’s closest relatives are at risk of becoming overburdened. The objectives are to describe the social psychological mechanisms and processes involved in a novel self-management intervention, and to evaluate their feasibility and acceptability from the stroke individuals’, the informal caregivers’ and the mentors’ perspectives, before implementation into a randomised controlled trial. Methods Qualitative interviews were conducted and analysed using a phenomenological approach. Informants comprised four stroke individuals, three informal caregivers and two mentors. The UK Medical Research Council Framework for developing and evaluating complex interventions was used in the evaluation design of the intervention. Results Six social psychological mechanisms were revealed as the mentors’ focus areas in their interaction with stroke individuals and informal caregivers: a) Tailored approach – by individual preferences, b) Dialogue-based communication, c) Development of a good relationship, d) Transfer of activities to everyday and social contexts, e) Involvement of relatives and social networks, and f) Supporting tools – to optimise actions and communication. Furthermore, interaction processes between the stroke individual and the informal caregiver and the mentors occurred, and generated processes of change and learning in the stroke individual and the informal caregiver. The mechanisms and processes described were perceived as feasible and acceptable to the informants – with the exception of the technological supporting tool. Conclusion The social psychological mechanisms and processes involved in the intervention indicated a positive association to self-management behaviour from the informants’ perspectives. The informants evaluated them to be relevant and meaningful in the novel self-management intervention. Trial registration ClinicalTrials.gov NCT03183960. Reg. June 15, 2017.

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.

A systematic review was undertaken to determine the efficacy of self-management interventions for people with stroke over the age of 65 in relation to psychosocial outcomes. PubMed, Embase, and PsycInfo were searched for randomized controlled clinical trials. Studies were eligible if the included people with stroke had a mean age ≥65 years in both the intervention and control group. Data on psychosocial measurements were extracted and an assessment of methodological quality was undertaken. Due to heterogeneity across the studies, the results were synthesized narratively. Eleven studies were identified. They included different self-management interventions in terms of theoretical rationales, delivery, and content. Seven psychosocial outcomes were identified: i) self-management, ii) self-efficacy, iii) quality of life, iv) depression, v) activities of daily living, vi) active lifestyle, and vii) other measures. Self-management interventions for people with stroke over the age of 65 may be beneficial for self-management, self-efficacy, quality of life, activity of daily living, and other psychosocial outcomes. However, low study quality and heterogeneity of interventions, as well as variation in time of follow-up and outcome measures, limit the possibility of making robust conclusions.