Ellen Gabrielsen Hjelle

• Bragstad, Line Kildal; Bronken, Berit Arnesveen; Sveen, Unni; Hjelle, Ellen Gabrielsen; Kitzmüller, Gabriele; Martinsen, Randi; Kvigne, Kari Johanne; Mangset, Margrete & Kirkevold, Marit (2019). Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: An explanatory sequential mixed methods study. BMC Medical Research Methodology.  ISSN 1471-2288.  19(59) . doi: 10.1186/s12874-019-0694-z Fulltekst i vitenarkiv. Vis sammendrag

  Background: Evaluation 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. Methods: This 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. Results: The 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. Conclusions: This 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 registration: ClinicalTrials.gov, NCT02338869; registered 10/04/2014. Keywords: Process evaluation, Implementation fidelity, Stroke, Psychosocial intervention, Mixed methods

• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Kirkevold, Marit; Zucknick, Manuela; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete; Thommessen, Bente & Sveen, Unni (2019). Effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke in Norway: A randomized controlled trial. Journal of Rehabilitation Medicine.  ISSN 1650-1977.  51(8), s 557- 565 . doi: 10.2340/16501977-2585 Vis sammendrag

  Abstract Objective: To evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. Design: Multicentre, prospective, randomized controlled trial. Subjects: Adults (aged ≥ 18 years) who had their first or recurrent stroke within the last month, were medically stable, had sufficient cognitive functioning to participate and understood and spoke Norwegian. Methods: A total of 322 participants were randomly assigned to the intervention (n = 166) or control (n = 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. The primary outcome was the proportion of participants with normal mood measured by the General Health Questionnaire-28 (GHQ-28). The secondary outcomes included health-related quality of life (Stroke and Aphasia Quality of Life Scale; SAQOL-39g), depression (Yale-Brown single-item questionnaire; Yale) and sense of coherence (SOC-13). Results: After controlling for the baseline values, no significant benefit was found in the intervention group over the control group (odds ratio (OR): 0.898: 95% confidence interval (95% CI): 0.54-1.50, p = 0.680) 6 months post-stroke. Conclusion: Psychosocial well-being improved during the first 6 months after stroke in both arms of the trial, but no statistically significant benefit of the dialogue-based intervention was found compared with usual care. Lay Abstract The aim of this study was to evaluate the effect of a dialogue-based intervention on psychosocial well-being 6 months after stroke. A total of 322 participants were assigned to an intervention (= 166) or control (= 156) group. Participants in the intervention group received up to 8 individual sessions aimed at supporting the coping and life skills of stroke survivors in addition to usual care. Psychosocial well-being improved during the first 6 months after the stroke in both arms of the trial. However, no benefit of the dialogue-based intervention was found compared with usual care.

• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Zucknick, Manuela; Kirkevold, Marit; Thommessen, Bente & Sveen, Unni (2019). The General Health Questionnaire-28 (GHQ-28) as an outcome measurement in a randomized controlled trial in a Norwegian stroke population. BMC Psychology.  ISSN 2050-7283.  7(18) . doi: 10.1186/s40359-019-0293-0
• Kitzmüller, Gabriele; Mangset, Margrete; Evju, Anne Svelstad; Angel, Sanne; Aadal, Lena; Martinsen, Randi; Bronken, Berit Arnesveen; Kvigne, Kari Johanne; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2019). Finding the way forward : the lived experience of people with stroke after participation in a complex psychosocial intervention. Qualitative Health Research.  ISSN 1049-7323.  29(12), s 1711- 1724 . doi: 10.1177/1049732319833366 Vis sammendrag

  Stroke patients’ well-being is threatened after stroke. A psychosocial intervention was developed for Norwegian stroke patients living in the community. Eight individual sessions between people with stroke and a trained health care professional were conducted 1 to 6 months post-stroke with one group of participants and 6 to 12 months post-stroke with another group. Subsequently, 19 of these stroke patients were interviewed to gain an in-depth understanding of their lived experience of the influence of the intervention on their adjustment process. Interview texts were analyzed using Ricoeur’s interpretation theory. Two participants did not personally find the intervention useful. The remaining participants greatly appreciated dialogues with the empathetic intervention personnel, feeling free to discuss their fears and worries. The intervention raised these participants’ awareness of their needs and resources. They were guided to resume their everyday life and adopt a future-oriented attitude. The intervention facilitated their meaning-making endeavors and post-stroke adjustment.

• Kirkevold, Marit; Bragstad, Line Kildal; Bronken, Berit Arnesveen; Kvigne, Kari Johanne; Martinsen, Randi; Hjelle, Ellen Gabrielsen; Kitzmüller, Gabriele; Mangset, Margrete; Angel, Sanne; Aadal, Lena; Eriksen, Siren; Wyller, Torgeir Bruun & Sveen, Unni (2018). Promoting psychosocial well-being following stroke: study protocol for a randomized, controlled trial. BMC Psychology.  ISSN 2050-7283.  6(12) . doi: 10.1186/s40359-018-0223-6 Fulltekst i vitenarkiv. Vis sammendrag

  Background: Stroke 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. Methods: The 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. Discussion: The 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

• Røe, Cecilie; Kirkevold, Marit; Andelic, Nada; Søberg, Helene L.; Sveen, Unni; Bautz-Holter, Erik; Jahnsen, Reidun Birgitta; Van Walsem, Marleen Regina; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Klevberg, Gunvor Lilleholt; Oretorp, Per; Habberstad, Andreas Hanssønn; Hagfors, Jon; Væhle, Randi; Engen, Grace & Gutenbrunner, Christoph (2018). The challenges of describing rehabilitation services: A discussion paper. Journal of Rehabilitation Medicine.  ISSN 1650-1977.  50, s 151- 158 . doi: 10.2340/16501977-2299 Vis sammendrag

  Objectives: To apply the Classi cation of Service Or- ganization in Rehabilitation (ICSO-R) classi cation of services to different target groups, include the user perspective, identify missing categories, and propose standardized descriptors for the categories from a Norwegian perspective. Design: Expert-based consensus conferences with user involvement. Subjects: Health professionals, stakeholders and users. Methods: Participants were divided into 5 panels, which applied the ICSO-R to describe the habilitation and rehabilitation services provided to children with cerebral palsy and people with Huntington’s disease, acquired brain injuries (traumatic brain injuries and stroke) and painful musculoskeletal conditions. Ba- sed on the Problem/Population, Intervention, Com- parison, Outcome (PICO) framework, the services were described according to the ICSO-R. Missing ca- tegories were identi ed. Results: The ICSO-R was found to be feasible and applicable for describing a variety of services pro- vided to different target groups in Norway, but the user perspective was lacking, categories were missing, and a need for standardized description of the categories was identi ed. Conclusion: The present work supports the need to produce an updated version of the ICSO-R and to en- courage national and international discussion of the framework. The ICSO-R has the potential to become a tool for the standardized assessment of rehabilita- tion services. For such purposes, more standardized descriptions of subcategories are necessary.

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• Bragstad, Line Kildal; Bronken, Berit Arnesveen; Sveen, Unni; Hjelle, Ellen Gabrielsen; Kitzmüller, Gabriele; Martinsen, Randi; Kvigne, Kari Johanne; Mangset, Margrete & Kirkevold, Marit (2019). Implementation fidelity in an RCT evaluating psychosocial well-being following stroke: an explanatory sequential mixed methods study.
• Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete & Kirkevold, Marit (2019). Interpreting neutral results in an intervention aimed at promoting psychosocial well-being following stroke: A process evaluation.
• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Kirkevold, Marit; Zucknick, Manuela; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete; Thommessen, Bente & Sveen, Unni (2019). The effect of a psychosocial intervention on well-being 6 months after stroke – a multicentre prospective randomized controlled trial.
• Hjelle, Ellen Gabrielsen Hjelle; Bragstad, Line Kildal; Kirkevold, Marit; Zucknick, Manuela; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete; Thommessen, Bente & Sveen, Unni (2019). The complexities of an intervention to promote psychosocial well-being after stroke: Implications for trial outcome.
• Mangset, Margrete; Kitzmüller, Gabriele; Evju, Anne Svelstad; Angel, Sanne; Aadal, Lena; Martinsen, Randi; Bronken, Berit Arnesveen; Kvigne, Kari Johanne; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2019). The influence of the assessment interviews on the control group participants in a complex psychosocial intervention study after stroke.
• Martinsen, Randi; Kitzmüller, Gabriele; Mangset, Margrete; Bronken, Berit Arnesveen; Evju, Anne Svelstad; Kvigne, Kari Johanne; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2019). Helsepersonells erfaringer med å gjennomføre psykososial støtte til personer med hjerneslag.
• Bragstad, Line Kildal; Bronken, Berit Arnesveen; Sveen, Unni; Hjelle, Ellen Gabrielsen; Kitzmüller, Gabriele; Martinsen, Randi; Kvigne, Kari Johanne; Mangset, Margrete & Kirkevold, Marit (2018). Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study. Part One..
• Bronken, Berit Arnesveen; Bragstad, Line Kildal; Sveen, Unni; Hjelle, Ellen Gabrielsen; Kitzmüller, Gabriele; Martinsen, Randi; Kvigne, Kari Johanne; Mangset, Margrete & Kirkevold, Marit (2018). Implementation fidelity in a complex intervention promoting psychosocial well-being following stroke: an explanatory sequential mixed methods study. Part Two..
• Kitzmüller, Gabriele; Mangset, Margrete; Evju, Anne Svelstad; Angel, Sanne; Aadal, Lene; Martinsen, Randi; Bronken, Berit Arnesveen; Kvigne, Kari Johanne; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2018). To find oneself - The lived experience of persons with stroke after participation in a complex psychosocial intervention.
• Martinsen, Randi; Kirkevold, Marit; Mangset, Margrete; Kitzmüller, Gabriele; Bronken, Berit Arnesveen; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni; Evju, Anne Svelstad & Kvigne, Kari Johanne (2018). Nurses’ and occupational therapists’ experiences of their roles in supporting stroke survivors during rehabilitation.
• Bragstad, Line Kildal; Bronken, Berit Arnesveen; Hjelle, Ellen Gabrielsen; Sveen, Unni; Martinsen, Randi; Kitzmüller, Gabriele; Kvigne, Kari; Mangset, Margrete & Kirkevold, Marit (2017). Promoting psychosocial wellbeing following stroke: Evaluating implementation fidelity in a multi-center RCT – a quantitative study of intervention adherence.
• Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete & Kirkevold, Marit (2017). Guidet egenbeslutning for å fremme psykososial helse etter hjerneslag. En samtalebasert intervensjon.
• Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari; Kitzmüller, Gabriele; Mangset, Margrete & Kirkevold, Marit (2017). Guidet egenbeslutning for å fremme psykososial helse etter hjerneslag. Ergoterapeuten.  ISSN 0800-3475.  60(6), s 31- 33
• Bronken, Berit Arnesveen; Bragstad, Line Kildal; Martinsen, Randi; Kitzmüller, Gabriele; Mangset, Margrete; Hjelle, Ellen Gabrielsen; Kvigne, Kari & Kirkevold, Marit (2017). Promoting psychosocial well-being following stroke: Facilitating implementation of a complex intervention in primary Healthcare..
• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Kirkevold, Marit; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete; Thommessen, Bente & Sveen, Unni (2017). Promoting Psychosocial well-being following stroke.
• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Kirkevold, Marit; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari Johanne; Kitzmüller, Gabriele; Mangset, Margrete; Thommessen, Bente & Sveen, Unni (2017). Psykososial helse etter hjerneslag - en kontrollert, randomisert multisenter studie.
• Kitzmüller, Gabriele; Mangset, Margrete; Evju, Anne Svelstad; Angel, Sanne; Aadal, Lena; Kvigne, Kari Johanne; Bronken, Berit Arnesveen; Martinsen, Randi; Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2017). Promoting psychosocial well-being following stroke: Stroke patients' experiences of participating in a complex psychosocial intervention.
• Martinsen, Randi; Kitzmüller, Gabriele; Mangset, Margrete; Evju, Anne Svelstad; Bronken, Berit Arnesveen; Bragstad, Line Kildal; Kvigne, Kari; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2017). Promoting psychosocial wellbeing following stroke: Nurses' and occupational therapists' experiences of delivering an individualized dialogue-based intervention to support stroke survivors the first six months following stroke.
• Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Sveen, Unni & Kirkevold, Marit (2016). Evaluating complex interventions: Methodological challenges of assessing intervention fidelity in a randomized controlled trial targeting psychosocial wellbeing following stroke.
• Hjelle, Ellen Gabrielsen; Bragstad, Line Kildal; Kirkevold, Marit; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari; Kitzmüller, Gabriele; Eriksen, Siren; Mangset, Margrete & Sveen, Unni (2016). Promoting psychosocial well-being following stroke: A randomized, single blind, controlled trial.
• Bragstad, Line Kildal & Hjelle, Ellen Gabrielsen (2015). Psychosocial wellbeing following stroke: A randomized, single blind, controlled trial.
• Bragstad, Line Kildal; Hjelle, Ellen Gabrielsen; Bronken, Berit Arnesveen; Martinsen, Randi; Kvigne, Kari; Kouwenhoven, Siren Eriksen; Mangset, Margrete; Sveen, Unni; Kitzmüller, Gabriele & Kirkevold, Marit (2015). Psychosocial wellbeing following stroke: A randomized, single blind, controlled trial.

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