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.

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.

Finding the Way Forward: The Lived Experience of People With Stroke After Participation in a Complex Psychosocial Intervention.

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.