Journal of Rehabilitation Medicine 51-8 | Page 22

558 E. Gabrielsen Hjelle et al. However, few dialogue-based psychosocial inter- ventions to support stroke survivors’ coping and life skills have been conducted by primary healthcare professionals in the municipalities. In Norway, imple- mentation of the Coordination Reform in 2012 (12) resulted in a shift in focus from primarily treating pa- tients in hospitals to a focus on prevention, improving coordination between different care levels, integrating care in the community, and strengthening healthcare in the municipalities. The overriding aim of the reform was to direct more investment towards primary care in order to curb increasing hospital expenditure. As part of this shift, providing rehabilitation near patients’ homes in the municipalities was encouraged. The dialogue-based intervention was developed and feasibility tested in accordance with the United King- dom Medical Research Council (UK MRC) guidance on developing and evaluating complex interventions (13, 14). The intervention was found to be feasible to conduct in the municipalities, was tailored for stroke survivors and designed to be delivered in the early rehabilitation phase starting 4–6 weeks after stroke onset (15). A guiding topical outline and worksheets were developed to support the dialogues. The topics included emotions, social relationships, bodily chan- ges, dynamic problem-solving, daily activities and identity (14, 15). The theoretical perspectives underpinning the inter- vention included Antonovsky’s (16) theory on saluto- genesis, sense of coherence (SOC), narrative theory (17) and ideas from guided self-determination (18). Based on the theoretical foundation and feasibility work, we hypothesized that support during the early adjustment phase following a stroke could lead to improvements in mood, reduced depression, enhanced health-related quality of life and improved understan- ding, manageability and meaning in their lives after stroke (14, 15). The present study evaluated the effect of a dialogue- based intervention in addition to usual care on psycho- social well-being 6 months after stroke. MATERIALS AND METHODS Trial design and participants This study was a multicentre, prospective, randomized control- led trial (RCT). Participants were recruited from 11 acute stroke or rehabilitation units in eastern Norway between November 2014 and November 2016. Patients who met these criteria were invited to participate: aged >18 years and had had an acute stroke within the past month, were medically stable, had sufficient cognitive functio- ning to provide informed consent and participate, and under- stood and spoke Norwegian. Exclusion criteria were: severe dementia, other serious somatic or psychiatric diseases or severe www.medicaljournals.se/jrm aphasia. Recruiting personnel assessed the cognitive function and aphasia, which were discussed with the rehabilitation team at the recruiting institutions. Interventions All participants received usual care. Usual care included acute treatment at stroke units and rehabilitation centres or in the municipality. All participants were followed up by their phy- sicians in accordance with the Norwegian clinical guidelines for treatment and rehabilitation after stroke (19) in addition to nursing and therapy input (e.g. through a multidisciplinary team) based on need and availability. The dialogue-based intervention consisted of 8 individual sessions involving the participant and a registered nurse (RN) or occupational therapist (OT) recruited via the recruiting institutions, other stroke rehabilitation units or the community healthcare. All intervention personnel (IP) were required to complete a 3-day training programme. Group seminars led by members of the research team were arranged for the IP during the study. The seminars were an arena for guidance and supervi- sion and allowed the research team to reinforce IP training and compliance to protocol in order to promote intervention fidelity. The same RN/OT worked with the participant through all sessions. Interventions were delivered mainly in the partici- pants’ homes. The first of the 8 sessions began shortly after randomization (4–8 weeks post-stroke), and the final session was completed within 6 months. The number of sessions was chosen to balance the ideal with the realistic (i.e. as few encounters as possible, but enough to provide adequate support). The sessions` content addressed feelings, thoughts and reflec- tions related to the patients’ experiences after stroke, and were based on topics highlighted as significant issues in the stroke literature and in the development and feasibility studies (14, 15). Theoretically, experiences of chaos and a lack of control were perceived as potential threats to well-being following stroke. It was assumed that sense of coherence (SOC) could be promoted by experiencing diverse life events as comprehensible, mana- geable and meaningful. To promote SOC, the participants were encouraged to relate their experiences. Narrative theories em­ phasize that human beings create meaning in their lives through telling stories. By guided self-determination, the intervention sought to empower the participants to make decisions on issues related to well-being based on their values and perspectives (14). More details on the topics of the dialogue-based sessions are provided in the Table SI and Table SII 1 . Further details regar- ding the development and adjustments of the intervention were provided in previous research (15). Outcomes The stroke aetiology, side localization of the stroke symptoms, cognitive function, and language difficulties were recorded at baseline after obtaining informed consent. Neurological deficits were evaluated using the National Institutes of Health Stroke Sca- le (NIHSS) upon admittance to the hospitals (20). Information regarding cognitive function (Mini Mental Status Evaluation; MMSE) was collected from the participant’s medical record. Participants were assessed prior to randomization using struc- tured outcome measures 1 month post-stroke (T1). In addition, the data collector recorded the patient’s age, sex, living situation, http://www.medicaljournals.se/jrm/content/?doi=10.2340/16501977-2585 1