From Intensive Care to Recovery: Feasibility of a Randomised Controlled Study Design Evaluating a Cognitive Rehabilitation Intervention for Critically Ill Patients.

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Learn more: PMC Disclaimer | PMC Copyright Notice Nurs Crit Care . 2026 Apr 13;31(3):e70490. doi: 10.1111/nicc.70490 Search in PMC Search in PubMed View in NLM Catalog Add to search From Intensive Care to Recovery: Feasibility of a Randomised Controlled Study Design Evaluating a Cognitive Rehabilitation Intervention for Critically Ill Patients Katrine Astrup Katrine Astrup 1 Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark 2 Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark 3 Department of Public Health, Aarhus University, Aarhus, Denmark Find articles by Katrine Astrup 1, 2, 3, ✉ , Helene Korvenius Nedergaard Helene Korvenius Nedergaard 4 Department of Anaesthesiology and Intensive Care, University Hospital of Southern Denmark, Lillebaelt Hospital Kolding, Kolding, Denmark 5 Department of Regional Health Research, University of Southern Denmark, Odense, Denmark Find articles by Helene Korvenius Nedergaard 4, 5 , Pia Dreyer Pia Dreyer 1 Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark 3 Department of Public Health, Aarhus University, Aarhus, Denmark Find articles by Pia Dreyer 1, 3 , Anna Holm Anna Holm 1 Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark 3 Department of Public Health, Aarhus University, Aarhus, Denmark Find articles by Anna Holm 1, 3 , Mette Møller Mette Møller 2 Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark Find articles by Mette Møller 2 , Trine Nørskov Haberlandt Trine Nørskov Haberlandt 4 Department of Anaesthesiology and Intensive Care, University Hospital of Southern Denmark, Lillebaelt Hospital Kolding, Kolding, Denmark Find articles by Trine Nørskov Haberlandt 4 , Rikke Sig Rikke Sig 2 Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark Find articles by Rikke Sig 2 , Nanna Rolving Nanna Rolving 2 Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark 3 Department of Public Health, Aarhus University, Aarhus, Denmark Find articles by Nanna Rolving 2, 3 Author information Article notes Copyright and License information 1 Department of Intensive Care, Aarhus University Hospital, Aarhus, Denmark 2 Department of Physiotherapy and Occupational Therapy, Aarhus University Hospital, Aarhus, Denmark 3 Department of Public Health, Aarhus University, Aarhus, Denmark 4 Department of Anaesthesiology and Intensive Care, University Hospital of Southern Denmark, Lillebaelt Hospital Kolding, Kolding, Denmark 5 Department of Regional Health Research, University of Southern Denmark, Odense, Denmark * Correspondence: Katrine Astrup ( [email protected] ) ✉ Corresponding author. Revised 2026 Mar 23; Received 2026 Mar 9; Accepted 2026 Mar 26; Issue date 2026 May. © 2026 The Author(s). Nursing in Critical Care published by John Wiley & Sons Ltd on behalf of British Association of Critical Care Nurses. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. PMC Copyright notice PMCID: PMC13076237  PMID: 41975232 ABSTRACT Background Survivors of critical illness frequently experience persistent cognitive impairment. However, structured cognitive rehabilitation interventions remain limited within intensive care pathways. While physical rehabilitation has received increasing attention, evidence guiding cognitive rehabilitation in intensive care unit (ICU) populations is sparse, and the feasibility of study procedures must be established before large‐scale evaluation. Aim To assess the feasibility of conducting a multi‐arm randomised controlled trial evaluating a cognitive rehabilitation intervention (ICU CogHab) for ICU survivors. Study Design A pragmatic, five‐arm randomised feasibility study was conducted across four ICUs at two Danish university hospitals. Feasibility outcomes included screening and recruitment, randomisation procedures, retention through 6‐month follow‐up and completion of patient‐reported and performance‐based outcome measures. Data were analysed descriptively to summarise feasibility parameters and outcome variability. Results Of 1679 patients screened, 115 met eligibility criteria and 83 were randomised. Recruitment was lower than anticipated, and retention at 6 months was 40%. Clinical data obtained from medical records were largely complete, whereas cognitive and patient‐reported outcomes were more difficult to complete at ICU discharge. Outcome measures demonstrated substantial variability. Conclusion This study shows that screening and randomisation procedures for a cognitive rehabilitation intervention are feasible within routine ICU practice. Retention and data completeness, particularly after hospital discharge, represent key challenges requiring refinement before further evaluation. Relevance to Clinical Practice Cognitive rehabilitation can be introduced within routine ICU workflows. However, the timing of assessments, follow‐up procedures and integration into clinical practice require optimisation. These findings inform pragmatic adaptations to support future evaluation and implementation of cognitive rehabilitation for ICU survivors. Trial Registration The study was prospectively registered on the Open Science Framework ( https://osf.io/b57fv/overview ) Keywords: cognitive rehabilitation, critical illness survivors, feasibility study, intensive care unit, randomised controlled design Impacts Statements What is known about the topic? ○ Cognitive impairment is a common and potentially persistent consequence of critical illness, yet structured cognitive rehabilitation remains underdeveloped and inconsistently integrated into ICU care pathways. ○ While complex rehabilitation interventions are increasingly advocated for ICU survivors, evidence on the feasibility of conducting randomised studies of cognitive rehabilitation across the ICU‐post‐discharge trajectory is limited. What this paper adds? ○ This study demonstrates that systematic screening, recruitment and randomisation to a cognitive rehabilitation intervention are feasible within routine ICU practice, while identifying retention and data completeness as key challenges, particularly after discharge. ○ By evaluating feasibility across multiple intervention pathways and assessment time points, the study provides empirical guidance to refine study procedures, assessment timing and follow‐up strategies before progression to a definitive trial ○ Together with prior intervention development work, these findings establish a coherent methodological foundation for future feasibility and implementation research in cognitive rehabilitation for ICU survivors. Abbreviations ADL activities of daily living ADL‐I activities of daily living interview BT brain training CAM‐ICU confusion assessment method for the intensive care unit CFS Clinical Frailty Scale CogHab cognitive rehabilitation intervention CONSORT consolidated standards of reporting trials CPAx Chelsea Critical Care Physical Assessment Tool CPAx‐D Chelsea Critical Care Physical Assessment Tool, Danish version cTTO composite time trade‐off DASAIM Danish Society of Anaesthesiology and Intensive Medicine EQ‐5D‐5L EuroQol Five Dimensions Questionnaire, five‐level version EQ VAS EuroQol visual analogue scale GDPR general data protection regulation ICDSC intensive care delirium screening checklist ICU intensive care unit IQR interquartile range MoCA Montreal Cognitive Assessment MRC Medical Research Council OSF Open Science Framework PADIS pain, agitation/sedation, delirium, immobility and sleep QoL quality of life QR (code) quick response RASS Richmond Agitation‐Sedation Scale REDCap research electronic data capture SAPS III Simplified Acute Physiology Score III SD standard deviation STS sit‐to‐stand TIDieR template for intervention description and replication 1. Introduction Survivors of critical illness commonly experience persistent long‐term sequelae involving physical, psychological and cognitive impairment, collectively referred to as post‐intensive care syndrome (PICS) [ 1 , 2 ]. Cognitive impairment, including deficits in attention, memory and executive function, is particularly prevalent and is associated with reduced quality of life (QoL), impaired independence and difficulty returning to everyday activities [ 3 , 4 , 5 , 6 ]. Despite its clinical importance, cognitive rehabilitation has received less attention than physical rehabilitation in intensive care unit (ICU) pathways [ 7 , 8 ]. 2. Background Rehabilitation research in intensive care has predominantly focussed on physical recovery, supported by growing evidence for early mobilisation and exercise‐based interventions [ 9 , 10 ]. In contrast, structured approaches addressing cognitive rehabilitation remain limited, despite the substantial burden of long‐term cognitive impairment. A recent umbrella review highlighted that current evidence on non‐pharmacological cognitive interventions for ICU patients remains sparse, heterogeneous, and insufficient to inform clinical practice [ 7 ]. To address this gap, a stakeholder‐informed cognitive rehabilitation intervention was developed (Astrup et al.—under review). In line with the Medical Research Council (MRC) framework for complex interventions [ 11 ], feasibility evaluations are an essential step prior to large‐scale randomised controlled trials [ 12 ], particularly in ICU populations characterised by clinical instability, fatigue, fluctuating cognition and heterogeneous recovery trajectories. Contextual variation across ICUs in staffing, organisational structures, resources and post‐discharge rehabilitation pathways further emphasises the importance of evaluating study procedures and intervention delivery in routine practice [ 13 ]. By focussing on feasibility rather than effectiveness, this study aims to generate methodological insights to inform the design and justification of a future definitive trial of cognitive rehabilitation for ICU survivors. 2.1. Aim The aim of this study was to assess the feasibility of conducting a randomised controlled trial of the ICU CogHab intervention among intensive care unit patients, focussing on screening and recruitment processes, randomisation procedures, retention and completion of follow‐up assessments at ICU discharge and 6‐month follow‐up and variability of outcome data. 3. Design and Methods 3.1. Study Design This study was a pragmatic randomised feasibility study, reported in accordance with the CONSORT extension for pilot and feasibility trials [ 14 ] and guided by the Medical Research Council (MRC) framework for complex interventions [ 11 ]. Five parallel groups were included: [ 1 ] mindfulness with ICU support only, [ 2 ] brain training with ICU support only, [ 3 ] mindfulness with ICU and post‐ICU support, [ 4 ] brain training with ICU and post‐ICU support and [ 5 ] usual care. As a feasibility study, the design focussed on assessing the practicality of study procedures and data collection to inform progression of the evaluation. Intervention acceptability and fidelity are reported separately. 3.2. Setting The study was conducted across four general medical and surgical adult ICUs at two Danish university hospitals. The units ranged from 6 to 10 beds each (approximately 30 beds in total) and provided level‐3 intensive care, including invasive mechanical ventilation and advanced haemodynamic support, with predominantly one‐to‐one nurse‐to‐patient staffing. The ICUs admitted a heterogeneous population of critically ill adults (≥ 18 years), including patients with sepsis, acute respiratory failure, cardiovascular conditions, major surgical complications and traumatic injury. Rehabilitation practices during and after ICU admission varied across the participating sites and formed part of routine clinical care and recovery. Early mobilisation and multidisciplinary rehabilitation were commonly initiated during ICU stay when clinically feasible. Two of the four ICUs routinely used patient diaries to support orientation and recovery, with structured diary follow‐up offered at one site. In addition, three sites provided structured follow‐up initiatives after ICU discharge, including peer‐support café meetings or outpatient consultations. Following ICU discharge, patients were transferred to general wards prior to hospital discharge either to home or to rehabilitation facilities, depending on clinical needs. After discharge, patients could receive routine municipality‐based rehabilitation services if clinically indicated. In Denmark, rehabilitation pathways are shaped by regional and municipal service provision, which may result in variation in access, coordination and continuity of post‐discharge support. These contextual factors formed part of the usual care environment in which the feasibility of the intervention and study procedures were evaluated. 3.3. Participating Patients Eligible participants were adults (≥ 18 years) admitted to the ICU for ≥ 24 h with an expected length of stay exceeding 48 h and sufficient Danish language capability. At inclusion, patients were required to be awake (Richmond Agitation‐Sedation Scale, RASS, −1 to +1) [ 15 ] and free from delirium, as assessed using the Confusion Assessment Method for the ICU (CAM‐ICU) [ 16 ] or the Intensive Care Delirium Screening Checklist (ICDSC) [ 17 ]. Exclusion criteria included primary neurological disease (e.g., traumatic brain injury, stroke, Parkinson's disease), pre‐existing dementia or severe cognitive impairment, cardiac arrest, severe substance abuse and palliative care status. 3.4. Screening, Randomisation and Allocation Patients were screened during weekday daytime hours, dependent on research staff availability. Screening and recruitment were undertaken by a small team of trained research physiotherapists, an occupational therapist, and a project nurse. Potentially eligible patients were identified through daily review of ICU admission lists and assessment of clinical status. Recruitment was conducted once predefined criteria for wakefulness and absence of delirium were fulfilled. Eligible patients received verbal and written study information and provided written informed consent prior to inclusion. Randomisation was performed electronically using the Research Electronic Data Capture (REDCap) [ 18 ] with a 1:1:1:1:1 allocation ratio, block sizes of 5–10, and stratification by study site. Due to the nature of the intervention, blinding of participants and clinical staff was not possible. 3.5. Sample Size The target sample size of 120 participants (approximately 24 per group) was determined pragmatically to provide sufficient data to estimate feasibility parameters and outcome variability. This estimate was informed by annual ICU admission rates, anticipated eligibility and consent proportions, and the planned 12‐month recruitment period. 3.6. Group Overview 3.6.1. Usual Care Usual care reflected routine ICU practice [ 19 , 20 ]. Control group patients were not contacted between ICU discharge and the 6‐month follow‐up assessment. 3.6.2. Intervention Patients allocated to an intervention group received usual care in addition to the ICU CogHab intervention, including either a Mindfulness or Brain Training rehabilitation component delivered using dedicated intervention boxes containing all relevant materials. The Mindfulness component comprised brief, audio‐guided exercises delivered via QR codes to support attentional regulation and emotional support, while the Brain Training component consisted of graded cognitive exercises targeting attention, memory and executive function through a structured activity book and simple supporting tools. The intervention was introduced at inclusion during ICU admission by a trained member of the research team and intended to accompany the patient from ICU discharge to follow‐up. ICU nurses supported day‐to‐day use during the ICU stay as part of routine care, following prior training and written guidance. Two of the intervention groups additionally received structured post‐ICU support for up to 6 months after ICU discharge, consisting of planned follow‐up contacts (e.g., in‐person visits, telephone calls, or text messages) to support continued engagement with the intervention materials. The intervention was designed to be flexible, allowing patients, with or without support from relatives, to adapt use according to individual capacity and preferences. Patients were encouraged to engage with the intervention activities at least once daily where feasible, with session duration and intensity adjusted to individual tolerance and recovery status. During ICU admission, intervention use was supported by bedside ICU nurses following prior training and written guidance materials. In the intervention groups receiving continued support, structured follow‐up contacts were provided for up to 6 months after discharge. These included in‐person visits during hospital admission as well as planned telephone calls or text messages after discharge to facilitate continued engagement with intervention materials. Detailed descriptions of intervention development, content and delivery are reported elsewhere (Astrup et al.—under review) and in accordance with the TIDieR checklist [ 21 ]. 3.7. Feasibility Outcomes and Data Collection 3.7.1. Feasibility Outcomes Feasibility outcomes were predefined and recorded throughout the study period: Screening and eligibility : Number of ICU admissions screened, number of patients meeting inclusion criteria and documented reasons for ineligibility. Recruitment and randomisation : Number of eligible patients providing written informed consent and undergoing randomisation, with reasons for refusal recorded. Retention and follow‐up : Completion of assessments at ICU discharge and 6 months post‐discharge, with reasons for attrition documented (death, withdrawal, loss to follow‐up). Feasibility of outcome measures : Completion rates and patterns of missing data for patient‐reported and performance‐based outcome measures. 3.7.2. Data Collection Procedures Data were collected prospectively by trained members of the research team using screening logs, structured assessment surveys and continuous monitoring of study procedures. Demographic and clinical data were extracted from electronic medical records. Patient‐reported and performance‐based outcome measures were collected during in‐person assessments or by telephone when required for follow‐up. Reasons for missing or incomplete data were systematically recorded. 3.7.3. Timing of Assessment and Data Type Data were collected at three predefined time points: baseline (at inclusion during ICU admission), ICU discharge and 6‐month post‐ICU discharge. Baseline data included sociodemographic and clinical characteristics obtained from electronic medical records. Clinical outcomes related to the ICU stay were recorded at ICU discharge; post‐ICU data were collected at 6‐month follow‐up. Patient‐reported and performance‐based outcome measures were assessed at ICU discharge and 6‐month follow‐up by trained physiotherapists and occupational therapists. Cognitive function was assessed using the Montreal Cognitive Assessment (MoCA; 0–30, higher scores indicating better performance) [ 22 , 23 ]. Health‐related quality of life was measured with the EQ‐5D‐5L and EQ visual analogue scale (EQ VAS; 0–100) [ 24 ]. EQ‐5D‐5L health states were converted into index values using the Danish cTTO‐based value set, anchored at 1.0 (full health) and 0 (death), with negative values indicating states worse than death [ 25 ]. Physical function was assessed at ICU discharge using the Chelsea Critical Care Physical Assessment Tool, Danish version (CPAx‐D; 0–50, higher scores indicating better function) [ 26 , 27 ], and at 6 months using the 30‐s sit‐to‐stand test (STS) [ 28 , 29 ]. Activities of daily living were assessed at 6 months using the Activities of Daily Living Interview (ADL‐I), generating Rasch‐based linear measures of ADL ability, with higher values indicating better performance [ 30 , 31 ]. An overview of all data sources, outcome measures and assessment time points is provided in Table 1 . TABLE 1. Overview of data collected, outcome measures and assessment time points. Time point Data domain Data measure/source Data type Baseline Demographics Age, gender, living arrangement Medical records Clinical characteristics ICU admission diagnosis, comorbidities, SAPS III, CFS Medical records ICU discharge Clinical characteristics ICU length of stay, mechanical ventilation, sedation, delirium, vasopressor use, dialysis, discharge destination Medical records Cognitive function MoCA Performance‐based Quality of life EQ‐5D‐5L Patient‐reported Physical function CPAx‐D Performance‐based 6‐month follow‐up Survival and healthcare use Survival, hospital length of stay, readmissions, discharge destination Medical records Cognitive function MoCA Performance‐based Quality of life EQ‐5D‐5L (index and VAS) Patient‐reported Physical function STS Performance‐based Activities of daily living ADL‐I Patient‐reported Open in a new tab Abbreviations: ADL‐I, activities of daily living interview; CFS, clinical frailty scale; CPAx‐D, Chelsea Critical Care Physical Assessment Tool, Danish version; EQ‐5D‐5L, EuroQol Five Dimensions Questionnaire (five‐level version); EQ VAS, EuroQol visual analogue scale; ICU, Intensive Care Unit; MoCA, Montreal Cognitive Assessment; SAPS III, Simplified Acute Physiology Score III; STS, 30‐s sit‐to‐stand test. 3.8. Data Analysis Analyses were descriptive, reflecting the feasibility objectives of the study. Demographic and clinical characteristics are reported as means and standard deviations (SD) for approximately normally distributed variables, or medians and interquartile ranges (IQR) for skewed data. Categorical variables were summarised as counts and proportions. Feasibility outcomes related to screening, recruitment, randomisation, retention and data completeness were summarised descriptively. Patient‐reported and performance‐based outcome measures were analysed descriptively to assess completion rates, patterns of missing data and distributional characteristics. Estimates of variability are presented to support estimation of parameters relevant for future trials, including considerations for sample size calculations. No formal hypothesis testing was undertaken. All analyses were conducted using STATA version 19.5 (StataCorp, College Station, TX, USA). 3.9. Ethical and Institutional Approvals The study was conducted in accordance with the Declaration of Helsinki [ 32 ] and approved 5 March 2024, by the local Research Ethics Committee (record no. 1‐10‐72‐137‐23). The study was prospectively registered on the Open Science Framework ( https://osf.io/b57fv/overview ). Given the vulnerability of critically ill patients, inclusion required that patients were awake (RASS−1 to RASS+1) and free from delirium at the time of inclusion. Capacity to provide informed consent was assessed by trained research staff, who provided verbal and written study information prior to obtaining written consent. All data were handled in accordance with the General Data Protection Regulation (GDPR) and stored securely with access restricted to authorised study personnel. 3.10. Disclosing the Use of Artificial Intelligence (AI) OpenAI's ChatGPT was used for language editing, including grammar correction, sentence structure refinement and clarification of wording. All AI‐assisted text was reviewed and revised to ensure accuracy and clarity of meaning. 4. Results 4.1. Patient Flow and Recruitment The feasibility study was conducted between June 2024 and December 2025 and included a 12‐month recruitment period with six‐month follow‐up. During the inclusion period, 2124 patients were admitted to the participating ICUs (Figure 1 ). Of these, 1679 patients were screened for eligibility, while 445 patients were not screened due to non‐screening days. Among screened patients, 115 met the inclusion criteria, and 83 consented to participate and were randomised. The predefined recruitment target of 120 patients was not achieved. Allocation was balanced across the five study groups (Figure 1 ). FIGURE 1. Open in a new tab Overview of the screening, inclusion and completion rate. Flow diagram shows screening of ICU admissions, reasons for exclusion, enrolment and allocation across the five study groups. 4.2. Retention and Attrition At 6 months, 33 patients of the 83 randomised patients (40%) completed follow‐up assessment (Figure 1 ). Attrition occurred across all study groups and was distributed relatively evenly over the post‐discharge period. Twelve patients died between enrolment and the 6‐month follow‐up. The most common reasons for non‐completion were deterioration in health, limited energy, competing healthcare needs and withdrawal of consent. Missing assessments at ICU discharge and follow‐up were primarily attributable to ongoing illness, readmissions, fatigue and cognitive or communication limitations. Detailed retention by study arm is presented in Figure 1 . 4.3. Characteristics of Enrolled Patients Demographic and clinical characteristics of the 83 enrolled patients are presented in Table 2 . The patients represented a heterogeneous ICU population with wide variation in age, illness severity, comorbidity burden and pre‐ICU frailty. Mean age was 63 years (range 23–87), and 41% were female. Cardiovascular conditions were the most common reason for ICU admission (47%), followed by post‐surgical (23%) and respiratory diagnoses (19%). Hypertension, cardiovascular disease and diabetes were the most prevalent comorbidities. Baseline characteristics were broadly comparable across the five study groups. TABLE 2. Baseline demographic and clinical characteristics of the participants. Total Group 1: Intervention Group 2: Intervention Group 3: Intervention Group 4: Intervention Group 5: Control MF (ICU support) BT (ICU support) MF (Cont. support) BT (Cont. support) Usual Care Sociodemographic n = 83 n = 16 n = 17 n = 16 n = 17 n = 17 Age, years, mean (SD) 63 (13.5) 64 (10.21) 65 (15.09) 65 (11.52) 59 (13.79) 62 (16.34) Gender, female, n (%) 34 (41) 8 (50) 8 (47) 7 (44) 6 (35) 5 (29) Civil status, n (%) Living with spouse/other (e.g., children) 54 (65) 13 (81) 11 (65) 10 (62.5) 10 (59) 10 (59) Living alone 27 (33) 3 (19) 5 (29) 6 (37.5) 6 (35) 7 (41) Other/Unknown < 3 < 3 < 3 < 3 < 3 < 3 Employment pre‐ICU, n (%) Full time (37 h) 21 (25) 4 (25) 4 (24) 3 (19) 6 (35) 4 (24) Part time (< 37 timer) 6 (7) 3 (19) < 3 < 3 < 3 < 3 Retired 33 (40) 5 (31) 8 (47) 8 (50) 5 (29) 7 (41) Other/Unknown 23 (28) 4 (25) 4 (24) 5 (31) 5 (29) 5 (29) Pre‐admission health behaviours, n Current tobacco use, n 7 < 3 < 3 < 3 < 3 < 3 Tobacco use*, n 5 < 3 < 3 < 3 < 3 < 3 Alcohol misuse*, n 5 < 3 < 3 < 3 < 3 < 3 Non‐prescribed drug use*, n * Former use < 3 < 3 < 3 < 3 < 3 < 3 Clinical outcomes (at inclusion) ICU Admission diagnosis**, n Cardiovascular 39 8 8 9 7 7 Respiratory 16 < 3 4 3 3 4 Sepsis 7 < 3 < 3 < 3 5 < 3 Post‐surgical 19 5 < 3 4 4 4 Trauma 6 < 3 < 3 < 3 < 3 < 3 Psychiatric < 3 < 3 < 3 < 3 < 3 < 3 Other < 3 < 3 < 3 < 3 3 < 3 ** More than one admission diagnosis possible BMI, kg/m 2 , mean (SD) 27 (5.4) 27 (3.2) 30 (8.4) 24 (2.8) 27 (3.9) 28 (5.5) Pre‐existing Comorbidities***, n None 8 (10) < 3 < 3 < 3 < 3 < 3 Hypertension 32 (39) 7 10 5 4 6 Diabetes 16 (19) 3 5 3 < 3 3 Cardio‐vascular disease 27 (33) 4 6 6 3 8 Respiratory (COPD, Asthma) 11 (13) < 3 3 < 3 < 3 4 Psychiatric 6 (7) < 3 3 < 3 < 3 < 3 Other/Unknown *** More comorbidities possible 45 (54) 7 10 10 11 7 CFS, n (%) CFS 1–3 54 (66) 12 (75) 9 (53) 13 (81) 11 (64) 10 (58) 2 CFS 4–5 20 (25) 4 (25) 5 (29) < 3 4 (24) 6 (36) 3 CFS 6–7 8 (9) < 3 3 (18) < 3 < 3 < 3 SAPS 3, mean (SD) 55 (14.4) 48 (11.4) 56 (14.3) 53 (13.1) 59 (12.7) 59 (18.8) Clinical outcomes (ICU discharge) n = 73 n = 14 n = 16 n = 13 n = 15 n = 15 ICU LOS, days, median (IQR) 6 (4–11) 4 (4–10) 7 (4–11) 6 (4–12) 10 (6–21) 5 (3–7.5) Mechanical ventilation, n (%) 39 (53) 10 (71) 8 (50) 3 (23) 9 (60) 9 (60) Duration of mechanical ventilation, days median (IQR) 3 (1–8) 1.5 (1–4) 4.5 (2.5–15) 32 (27–37) 9 (2–16) 2 (1–3) Sedation exposure (RASS < −1), n (%) 45 (62) 10 (71) 12 (75) 4 (31) 10 (67) 9 (60) Duration of sedation, days, median (IQR) 2 (1–6) 2 (1–2) 3 (1–9) 8 (4.5–13) 3 (2–11) 2 (1–3) Delirium (ICDSC/CAM‐ICU positive), n (%) 19 (26) 3 (21) 6 (37.5) 3 (23) 5 (33) 2 (13) Duration of ICU Delirium, days, median (IQR) 2 (1–3) 3 (1–9) 1.5 (1–3) 3 (3–3) 1 (1–2) 2 (1–3) Vasopressor support during ICU, n (%) 61 (84) 11 (79) 15 (94) 9 (69) 13 (87) 12 (80) Days with vasopressor support, days, median (IQR) 3 (1–7) 2 (1–5) 3 (1–5) 6 (2–7) 8 (2–11) 2.5 (1.5–3) Dialysis during ICU, n (%) 10 (14) 2 (14) 2 (12.5) 3 (23) 3 (20) 0 (0) Days with dialysis during ICU, days, median (IQR) 4 (3–31) 3.5 (3–4) 26 (2–50) 17 (4–38) 3 (2–31) 0 Destination at ICU discharge, n (%) 68 (92) 13 14 12 14 15 General ward 4 (6) 1 2 0 1 0 Other hospital Home/Rehab facility 1 (2) 0 0 1 0 0 Clinical outcomes (follow‐up) n = 33 n = 7 n = 6 n = 4 n = 6 n = 10 Hospital LOS, days, median (IQR) 14 (8–23) 15 (6–33) 18.5 (10–21) 9.5 (5.5–17.5) 32 (23–35) 11.5 (7.5–14) Re‐admission to ICU, n (%) 3 (9) 0 1 0 2 0 Re‐admission to hospital, n (%) 12 (36) 1 2 3 4 2 Destination post‐hospital, n (%) Home 30 7 5 4 6 8 Nursing home/Rehab facility 2 0 1 0 0 1 Other 1 0 0 0 0 1 Open in a new tab Note: Values are presented as mean (SD), median (IQR), or n (%). Sample size ( n ) varies across sections due to deaths and dropout during ICU stay and follow‐up as well as incomplete data collection for some variables. Patient flow and reasons for attrition are presented in Figure 1 . Abbreviations: BMI, body mass index; BT, brain training; CAM‐ICU, confusion assessment method for the intensive care unit; CFS, Clinical Frailty Scale; (1) CFS 1–3 (very fit to managing well); (2) CFS 4–5 (vulnerable to mildly frail); (3) CFS 6–7 (moderately to severely frail); Cont. support, intervention support during and after ICU; ICDSC, Intensive Care Delirium Screening Checklist; ICU support, Intervention support in the ICU only; MF, mindfulness; LOS, length of stay; RASS, Richmond Agitation‐Sedation Scale; SAPS 3, Simplified Acute Physiology Score 3. 4.4. Clinical Outcomes (ICU Discharge and Follow‐Up) Clinical outcomes derived from medical records were available for most patients with minimal missing data (Table 3 ). Among the 73 patients discharged alive from ICU, the median ICU length of stay was 6 days (range 2–60). Mechanical ventilation was required in 53% of the patients, sedation exposure was common (62%), 26% experienced delirium during their ICU stay, and vasopressor support was frequently required (84%). Among the 33 patients completing 6‐month follow‐up, the median hospital length of stay was 14 days (range 3–75). Over the 6‐month follow‐up period, 9% of patients were readmitted to the ICU and 36% experienced at least one hospital readmission (see Table 3 ). TABLE 3. Patient‐reported and performance‐based outcomes at ICU discharge and 6‐month follow‐up. Total Group 1: Intervention Group 2: Intervention Group 3: Intervention Group 4: Intervention Group 5: Control MF (ICU support), n = 14 BT (ICU support), n = 16 MF (Cont. support), n = 13 BT (Cont. support), n = 15 Usual care, n = 15 ICU discharge ( n = 73) MoCA, median (IQR) ( n = 66) 22 (18–25) 21.5 (19.5–27.5) 19.5 (16–23) 23 (19–25) 22 (14–25) 22 (18–24) EQ‐5D‐5L Index , median (IQR) ( n = 55) EQ‐5D‐5L VAS , median (IQR) ( n = 55) 0.48 (0.32–0.78) 45 (25–65) 0.78 (0.26–0.86) 50 (10–95) 0.46 (0.36–0.66) 30 (25–50) 0.36 (0.29–0.82) 45 (17.5–62.5) 0.412 (0.35–0.58) 35 (25–50) 0.60 (0.36–0.74) 45 (40–67.5) CPAx‐D, median (IQR) ( n = 63) 37 (29–41) 39 (33–43) 36 (24–37) 41 (36–46) 35 (22–40) 37 (30–39) Follow‐up ( n = 33) MoCA, median (IQR) ( n = 33) 26 (24–28) 27 (24–28) 25 (24–26) 28 (27–29) 26.5 (17–27) 27.5 (24–29) EQ‐5D‐5L Index , median (IQR) ( n = 32) 0.88 (0.83–0.93) 0.86 (0.76–0.95) 0.84 (0.82–0.92) 0.86 (0.85–0.94) 0.92 (0.84–0.95) 0.89 (0.85–0.92) EQ‐5D‐5L VAS , median (IQR) ( n = 33) 80 (65–85) 70 (50–80) 87.5 (60–90) 87.5 (75–95) 77.5 (35–80) 80 (70–85) ADL‐I, median (IQR) ( n = 32) 3.67 (2.66–5.14) 4.4 (2.66–5.14) 2.97 (2.81–3.37) 4.18 (3.67–4.4) 5.14 (3.96–5.14) 2.66 (1.98–3.96) SST, median (IQR) ( n = 28) 12 (10–16) 13 (10–15) 10 (9–17) 14 (8–20) 12 (10–12) 13 (9–16) Open in a new tab Note: Values are presented as median [IQR] or n (%). Abbreviations: ADL‐I, Activities of Daily Living‐Interview; BT, brain training; Cont. support, continued support during and after ICU; CPAx‐D, Chelsea Critical Care Physical Assessment Tool, Danish version; EQ‐5D‐5L, EuroQol 5‐Dimension 5‐Level; EQ‐5D‐5L VAS , EuroQol visual analogue scale; EQ‐5D‐5L Index , EQ‐5D utility index; ICU, intensive care unit; ICU support, intervention support in the ICU only; MF, mindfulness; MoCA, Montreal Cognitive Assessment; SST = 30‐s sit‐to‐stand test. 4.5. Completion of Assessments and Outcome Measures Completion of the patient‐reported and performance‐based outcome measures at ICU discharge was limited by fluctuating alertness, ongoing illness, delirium, fatigue and unplanned transfers to other hospital ICUs or general wards, reducing opportunities for in‐person assessment within the intended timeframe. ICU discharge assessments were feasible in 66 of 73 patients (Table 3 ). Among assessed patients, outcome measures demonstrated substantial variability. Median MoCA score was 22 (range 5–29), consistent with cognitive impairment in this population. Median EQ‐5D‐5L index was 0.48 (range −0.04 to 1.00) and median EQ‐VAS was 45 (range 5–100), indicating considerable limitations in self‐rated health status. Physical function was reduced, with a median CPAx‐D score of 37 (range 14–49). At 6‐month follow‐up, assessments were feasible in 33 patients. Outcome measures continued to show heterogeneity across participants (Table 3 ). Median MoCA score was 26 (range 24–28). Health‐related quality of life was higher than at ICU discharge, with a median EQ‐5D‐5L index of 0.88 (range 0.43–1.00) and EQ‐VAS of 80 (range 15–100), indicating continued limitations in self‐rated health status. Functional outcome measures at follow‐up were variable, with a median ADL‐I score of 3.67 (IQR 2.66–5.14) and sit‐to‐stand performance of 12 repetitions (IQR 10–16). Detailed distributions are presented in Table 3 . No adverse events or consequences related to study assessments or procedures were observed. 4.6. Modifications to Assessment and Study Procedures Minor procedural modifications were required during the study period to enhance feasibility. Eligibility procedures were clarified to ensure that patients who met the predefined inclusion criteria (≥ 24 h with an expected remaining stay > 48 h at the time of inclusion) at enrolment were not excluded if they experienced early clinical improvement or early ICU discharge. Patients with a history of neurological events were included when medical records indicated no residual cognitive impairment that would limit meaningful participation. To support consistent intervention delivery, a study‐specific notification prompt was introduced into the electronic nursing record. Planned assessor blinding proved infeasible in routine clinical practice and was therefore discontinued after the initial phase of recruitment (approximately the first 20 participants). No changes were made to the core intervention components or outcome measures. Collectively, these procedural clarifications increased the pragmatism of recruitment and study procedures and improved their alignment with routine ICU practice. 5. Discussion This feasibility study investigated the processes and practical conduct of a multi‐arm randomised evaluation of a cognitive rehabilitation intervention for ICU patients. Several core study procedures were feasible, including systematic screening, eligibility assessment and randomisation, all of which worked as intended within routine clinical workflows of four ICUs. However, feasibility was influenced by limited screening coverage and a low proportion of eligible patients. Of 2124 ICU admissions during the study period, 79% were screened and 6.8% met the inclusion criteria. Screening was limited to weekday daytime hours and therefore dependent on research staff availability. In addition, eligibility criteria requiring patients to be awake, free from delirium and expected to remain in ICU beyond 48 h restricted enrolment within a clinically heterogeneous ICU population. Future studies may improve recruitment feasibility by extending screening procedures, strengthening integration with clinical teams and allowing more flexible enrolment timing aligned with recovery trajectories. In contrast, retention and outcome data completeness emerged as the main feasibility challenges, particularly after hospital discharge. Loss to follow‐up was primarily driven by health deterioration, readmissions, competing healthcare demands, and perceived limited relevance of participation, indicating that sustaining engagement during recovery after critical illness represents a central feasibility challenge. These observations are consistent with previous ICU survivorship research. Methodological reviews and longitudinal follow‐up studies demonstrate that, although recruitment and in‐hospital procedures are achievable in ICU populations, maintaining engagement and achieving complete data after discharge is considerably more challenging, especially in the context of ongoing morbidity, cognitive limitations, competing healthcare demands and the complex organisational environment of the ICU and post‐ICU care [ 33 , 34 ]. Our findings extend this understanding by demonstrating how these challenges unfold in a multi‐arm cognitive rehabilitation study conducted across transitions in care. Feasibility of outcome assessments further reflected a similar pattern. While clinical measures were generally obtainable during the ICU stay or at ICU discharge, the MoCA and EQ‐5D‐5L assessments were less feasible at ICU discharge, mainly due to fatigue, fluctuating cognition or delirium and competing priorities during care transitions. This aligns with previous work emphasising the practical and cognitive challenges of conducting structured outcome assessments early after critical illness [ 34 , 35 , 36 ]. In contrast, incomplete CPAx assessments at ICU discharge were mainly related to the limited availability of trained physiotherapists rather than constraints of the instrument itself, consistent with previous reports of high CPAx feasibility when integrated into routine practice [ 37 , 38 ]. Assessment completions improved when completed on the general ward, supporting recommendations to align assessment timing with clinical transitions rather than fixed ICU discharge milestones [ 36 ]. Feasibility studies of post‐ICU rehabilitation similarly emphasise the influence of timing, eligibility processes and contextual factors. Connolly et al. reported that post‐discharge exercise‐based rehabilitation was acceptable and safe among enrolled patients, yet the proportion of eligible patients among those screened was low, highlighting challenges in identifying suitable candidates early after critical illness [ 39 ]. Similarly, Major et al. described good retention in a home‐based interdisciplinary rehabilitation programme for patients with PICS but noted difficulties in delivering all planned intervention components and adapting to heterogeneous recovery trajectories [ 40 ]. Together with the present findings, these studies indicate that feasibility is strongly influenced not only by patients' characteristics and intervention design but also by organisational context and competing demands across transitions in care from the ICU to home. Notably, follow‐up completion in the present study was highest in the control group, despite the absence of an active intervention. This suggests that continued participation may not be driven solely by intervention exposure but also by the provision of a structured follow‐up contact itself, which may be perceived as valuable by ICU survivors and reflect a broader need for follow‐up after critical illness. 5.1. Strengths and Limitations This study has several strengths. The multi‐site design enabled assessment of feasibility across ICUs with differing organisational structures and clinical workflows, enhancing transferability of the findings. The multi‐arm structure enabled simultaneous testing of feasibility across different intervention pathways, generating comparative operational insights within a single feasibility study. Feasibility outcomes were predefined and systematically collected, providing a transparent description of recruitment, retention and assessment feasibility. The pragmatic study design further enhances relevance for future implementation in routine clinical practice. Several limitations should be acknowledged. Attrition and missing data reduced the precision of estimates related to retention and outcome completion. Blinding could not be maintained beyond the initial phase, and a pragmatic unblinded assessment approach was adopted, which may have introduced a risk of assessment bias despite being appropriate to the clinical context. Furthermore, although attrition was not associated with baseline characteristics or group allocation among included participants, patients with greater illness severity or persistent delirium were less likely to become eligible, which may limit generalisability to the most clinically unstable ICU populations. 5.2. Implications for Further Research Several implications for future research emerge from these findings. First, the timing of outcome assessments should align with clinical transitions rather than fixed ICU discharge time points, as completion rates improved when assessments were conducted on the general ward. Second, follow‐up procedures require refinement, including individualised or multimodal contact strategies that account for patients' fluctuating health status and competing healthcare demands across recovery. Third, intervention delivery and fidelity of outcome assessment depend on workflow integration and staff availability, underscoring the importance of training, role clarity and pragmatic implementation support. Involving relatives in follow‐up processes may further support engagement for selected patients. Finally, although the multi‐arm design was appropriate for feasibility evaluation, future evaluations may benefit from a simplified design to reduce organisational complexity and implementation within routine clinical settings. In line with the MRC framework, these findings represent an iterative refinement phase. Key elements of the study design are feasible; however, targeted modifications are required to improve retention, outcome data completeness and feasibility of early cognitive patient‐reported and performance‐based assessment before progression to a pilot or definitive trial. In addition, variance estimates derived from this feasibility evaluation may inform sample size calculations for future trials. 6. Conclusion This study demonstrates that systematic screening, recruitment and randomisation of ICU patients to a cognitive rehabilitation intervention are feasible within routine ICU practice. Retention during hospitalisation reflected the clinical vulnerability of the population, whereas attrition increased after hospital discharge, resulting in reduced follow‐up completion and outcome data completeness. Loss to follow‐up was primarily related to health deterioration, readmissions, competing healthcare demands, and limited feasibility of outcome assessments early in the recovery phase. These findings indicate that future evaluations should prioritise refinement of follow‐up procedures, alignment of assessment timing with clinical transitions and selection of outcomes that remain feasible across the recovery trajectory. With these targeted methodological adjustments, progression to further evaluation is supported. Author Contributions K.A. conceived and designed the study, coordinated data collection, conducted the analyses and drafted the manuscript. N.R., H.K.N., P.D. and A.H. contributed to study design and provided methodological and clinical supervision. M.M. and T.N.H. contributed to patient screening, data collection, intervention support, outcome assessments and data management. R.S. contributed to data collection, intervention support, and outcome assessments. All authors contributed to manuscript revision, approved the final version and accept accountability for the work. Funding This study was funded by the Novo Nordic (grant no. NNF20OC0061394) and Aarhus University. The funders had no role in the design, conduct or reporting of the study. Ethics Statement The study was conducted in accordance with the Declaration of Helsinki and approved 5 March 2024, by the local Research Ethics Committee (record no. 1‐10‐72‐137‐23). Consent Written informed consent was obtained from all participants prior to inclusion. Conflicts of Interest The authors declare no conflicts of interest. Acknowledgements The authors thank patients, relatives and clinical staff at the participating ICUs for their time and support during the study. Data Availability Statement The datasets generated and analysed during the current study are not publicly available due to data protection regulations but are available from the corresponding author on reasonable request. References 1. Yuan C., Timmins F., and Thompson D. R., “Post‐Intensive Care Syndrome: A Concept Analysis,” International Journal of Nursing Studies 114 (2021): 103814. [ DOI ] [ PubMed ] [ Google Scholar ] 2. Needham D. 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Data Availability Statement The datasets generated and analysed during the current study are not publicly available due to data protection regulations but are available from the corresponding author on reasonable request. 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