Perceived study-induced influence on the control group in a randomized controlled trial evaluating a complex intervention to promote psychosocial well-being after stroke: a process evaluation

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  • Margrete Mangset, University of Oslo
  • ,
  • Gabriele Kitzmüller, UiT The Arctic University of Norway
  • ,
  • Anne S. Evju, UiT The Arctic University of Norway
  • ,
  • Sanne Angel
  • Lena Aadal
  • Randi Martinsen, Inland Norway University of Applied Sciences
  • ,
  • Berit Arnesveen Bronken, Inland Norway University of Applied Sciences
  • ,
  • Kari J. Kvigne, Inland Norway University of Applied Sciences, Nord University
  • ,
  • Line K. Bragstad, University of Oslo
  • ,
  • Ellen Gabrielsen Hjelle, University of Oslo
  • ,
  • Unni Sveen, University of Oslo, Oslo Metropolitan University
  • ,
  • Marit Kirkevold, University of Oslo, Oslo Metropolitan University

Background: A commonly applied control condition in trials evaluating complex interventions in rehabilitation research is “usual care.” The main challenge is to ensure that the control group receives genuine usual care as delivered in everyday clinical practice. The assessment interviews and dialogues with the data collectors may influence the control group participants’ reflections on their condition and adjustments. This represents a threat to the internal validity of the trial. Thus, the aim of this study was to explore the perceived study-induced influence of assessment interviews on the adjustment of the members of a control group in a randomized clinical trial. The aim of the trial was to test a dialogue-based psychosocial intervention aiming at promoting the psychosocial well-being and adjustment of stroke survivors. Methods: Fifteen participants in the control group of a multicenter stroke rehabilitation trial participated in narrative semi-structured interviews. Ricoeur’s interpretation theory guided the analysis. Results: The perceived study-induced influence of the assessment interviews on the adjustment process of members of the control group varied considerably. The results demonstrated that the assessment interviews facilitated some participants’ feelings of control and their ability to cope. Other participants’ statements indicate that they relied on their existing personal capacity to cope and adjust and that the assessment interviews did not make any difference either on their coping ability or on their process of adjustment. Five themes were identified that described the perceived study-induced influence of the assessment interviews in the control group. The themes illustrated that the assessments served as a safety net, enhanced awareness and understanding, encouraged seeking support, allowed the opportunity to vent disappointment, or did not make any difference either way. Conclusions: RCT assessment interviews may influence the adjustment process and represent a serious problem in measuring interventions over time in trials of complex interventions in rehabilitation research. To uphold rigor and stringency, the usual care control conditions should be thoroughly assessed and described. Informing participants only about the treatment they were allocated to receive might counteract the potential to dilute the difference between the two arms of the trial. Trial registration: ClinicalTrials.gov NCT02338869. Registered on October 4, 2014

Original languageEnglish
Article number850
JournalTrials
Volume22
ISSN1468-6708
DOIs
Publication statusPublished - Nov 2021

Bibliographical note

Publisher Copyright:
© 2021, The Author(s).

    Research areas

  • Bias, Complex interventions, Control groups, Process evaluation, RCT (randomized controlled trials), Rehabilitation research, Research design, Stroke, Usual care

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