ICU CogHab cognitive rehabilitation feasibility study in ICU survivors with cognitive impairment
This randomised controlled trial was designed as a feasibility study to assess the implementation of a cognitive rehabilitation intervention known as ICU CogHab. The study took place in four intensive care units located at two Danish university hospitals. The target population consisted of ICU survivors who exhibited cognitive impairment. A total of 1679 patients were screened for eligibility. Of these, 115 patients met the eligibility criteria. Ultimately, 83 patients were randomised into the study arms. The comparator arm was not reported in the available data. The primary focus of the analysis was on feasibility outcomes rather than efficacy. These outcomes encompassed the rates of screening, recruitment, randomisation, retention, and the completion of outcome measures.
The intervention involved a cognitive rehabilitation program delivered to the randomised cohort. The study protocol included follow-up assessments extending over a period of 6 months. Data collection relied on both patient-reported outcomes and performance-based outcome measures. Clinical data completeness was largely achieved throughout the study duration. However, the completion of cognitive and patient-reported outcomes proved more difficult at the time of ICU discharge compared to later time points.
Key results regarding retention showed that 40% of the randomised participants were retained through the 6-month follow-up period. Absolute numbers for specific adverse events were not reported. Serious adverse events were not reported. Discontinuations were not reported. Tolerability data were not reported. The study did not provide specific p-values or confidence intervals for the primary feasibility metrics. The direction of effect for retention was not explicitly quantified beyond the percentage reported.
Several limitations were identified in the study design and execution. Recruitment was lower than anticipated by the study planners. Retention at 6 months was 40%, which may be considered suboptimal for a definitive efficacy trial. Outcome measures demonstrated substantial variability across the different assessments. The difficulty in completing cognitive and patient-reported outcomes at ICU discharge suggests potential barriers to data collection in the acute recovery phase. These factors must be addressed before the intervention can be scaled.
In terms of clinical implications, cognitive rehabilitation can be introduced within routine ICU workflows. However, the timing of assessments, follow-up procedures, and integration into clinical practice require optimisation to improve retention and data completeness. The study confirms that the intervention is feasible but highlights the need for structural adjustments to the care pathway. Future trials will need to address the challenges of early data collection and long-term participant engagement.
Several questions remain unanswered regarding the efficacy of this specific intervention. The lack of a reported comparator limits the ability to draw direct conclusions about relative benefit. The substantial variability in outcome measures suggests that standardisation is required. The study was a feasibility study and not a large-scale evaluation of clinical benefit. Funding or conflicts of interest were not reported. The certainty of the findings is limited by the feasibility nature of the trial and the incomplete reporting of certain metrics.