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BackgroundStroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.MethodsThe study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15–20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.DiscussionThe intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.Trial registrationNCT02338869; registered 10/04/2014 (On-going trial).

BackgroundExtensive studies have documented the complex and comprehensive psychosocial consequences of stroke. Psychosocial difficulties significantly affect long-term functioning and quality of life. Many studies have explored psychosocial interventions to prevent or treat psychosocial problems, but most have found modest effects. This study evaluated, from the perspective of adult stroke survivors, (1) the content, structure and process and (2) experienced usefulness of a dialogue-based psychosocial nursing intervention in primary care aimed at promoting psychosocial health and wellbeing.MethodsThis was part of a feasibility study guided by the UK MRC complex interventions framework. It consisted of dialogue-based encounters with trained health professionals during approximately the first year poststroke. It was tested in two formats; individual or group encounters. Inclusion criteria were: Acute stroke, above 18 y.o., sufficient physical and cognitive functioning to participate. Data were collected immediately before, during and 14 days after the completion of the intervention. Pre- and post-data included medical and demographic data, quality of life, emotional wellbeing, life satisfaction, anxiety and depression. Qualitative interviews focusing on participant experiences were conducted two weeks following the intervention. Log notes taken by the health professionals conducting the intervention and work sheets filled in by participants also comprised data. Data analysis was case-oriented. The structured instruments were analysed regarding completeness of data and indication of changes in outcome variables. The qualitative interviews, log notes and work sheets were analysed using thematic content analysis.ResultsTwenty-five stroke survivors (17 men, 8 women), median age 64 (range 33–89), participated. Physical limitations varied from mild to severe. Seven participants had moderate to severe expressive aphasia. The participants found the content and process of the intervention relevant. Both the individual and group formats were found useful. Patients with aphasia reported that there were too few encounters (eight encounters were originally planned). The participants underscored the benefits of being supported through a difficult time, having a chance to tell and (re)create their story and being supported in their attempts to cope with the situation.ConclusionsThis study provides initial support for the usefulness of the psychosocial intervention and highlights areas requiring further consideration and development.Trial registration numberClinicalTrials.gov Identifier: NCT01912014

BackgroundEvaluation of complex interventions should include a process evaluation to give evaluators, researchers, and policy makers greater confidence in the outcomes reported from RCTs. Implementation fidelity can be part of a process evaluation and refers to the degree to which an intervention is delivered according to protocol. The aim of this implementation fidelity study was to evaluate to what extent a dialogue-based psychosocial intervention was delivered according to protocol. A modified conceptual framework for implementation fidelity was used to guide the analysis.MethodsThis study has an explanatory, sequential two-phase mixed methods design. Quantitative process data were collected longitudinally along with data collection in the RCT. Qualitative process data were collected after the last data collection point of the RCT. Descriptive statistical analyses were conducted to describe the sample, the intervention trajectories, and the adherence measures. A scoring system to clarify quantitative measurement of the levels of implementation was constructed. The qualitative data sources were analyzed separately with a theory-driven content analysis using categories of adherence and potential moderating factors identified in the conceptual framework of implementation fidelity. The quantitative adherence results were extended with the results from the qualitative analysis to assess which potential moderators may have influenced implementation fidelity and in what way.ResultsThe results show that the core components of the intervention were delivered although the intervention trajectories were individualized. Based on the composite score of adherence, results show that 80.1% of the interventions in the RCT were implemented with high fidelity. Although it is challenging to assess the importance of each of the moderating factors in relation to the other factors and to their influence on the adherence measures, participant responsiveness, comprehensiveness of policy description, context, and recruitment appeared to be the most prominent moderating factors of implementation fidelity in this study.ConclusionsThis evaluation of implementation fidelity and the discussion of what constitutes high fidelity implementation of this intervention are crucial in understanding the factors influencing the trial outcome. The study also highlights important methodological considerations for researchers planning process evaluations and studies of implementation fidelity.Trial registrationClinicalTrials.gov, NCT02338869; registered 10/04/2014.Electronic supplementary materialThe online version of this article (10.1186/s12874-019-0694-z) contains supplementary material, which is available to authorized users.

Objective: To evaluate the effect of a dialogue-based intervention targeting psychosocial well-being at 12 months post-stroke. Design: Multicenter, prospective, randomized, assessor-blinded, controlled trial with two parallel groups. Setting: Community. Subjects: Three-hundred and twenty-two adults (⩾18 years) with stroke within the last four weeks were randomly allocated into intervention group ( n = 166) or control group ( n = 156). Interventions: The intervention group received a dialogue-based intervention to promote psychosocial well-being, comprising eight individual 1–1½ hour sessions delivered during the first six months post-stroke. Main measures: The primary outcome measure was the General Health Questionnaire-28 (GHQ-28). Secondary outcome measures included the Stroke and Aphasia Quality of Life Scale-39g, the Sense of Coherence scale, and the Yale Brown single-item questionnaire. Results: The mean (SD) age of the participants was 66.8 (12.1) years in the intervention group and 65.7 (13.3) years in the control group. At 12 months post-stroke, the mean (SE) GHQ-28 score was 20.6 (0.84) in the intervention group and 19.9 (0.85) in the control group. There were no between-group differences in psychosocial well-being at 12 months post-stroke (mean difference: −0.74, 95% confidence interval (CI): −3.08, 1.60). The secondary outcomes showed no statistically significant between-group difference in health-related quality of life, sense of coherence, or depression at 12 months. Conclusion: The results of this trial did not demonstrate lower levels of emotional distress and anxiety or higher levels of health-related quality of life in the intervention group (dialogue-based intervention) as compared to the control group (usual care) at 12 months post-stroke.