An interventional study of Early Cognitive Training in Intensive Care Units, Delirium, Cognitive Dysfunction, sponsored by Mount Carmel Health System. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-27.
Sponsored by Mount Carmel Health System · Not applicable, Interventional, and Supportive care
The purpose of this study is to see how early cognitive training (participation/involvement in activities to stimulate the brain) in the Intensive Care Unit (ICU) affects the number of patients who experience delirium (confusion) and cognitive impairment (problems with thinking). Reports have shown that 30% to 80% of all ICU patients will have some type of cognitive impairment: remembering, paying attention, solving problems, organizing, and working on complex tasks for some time after they leave the hospital.
Occupational therapy will do an assessment after an order is received from the doctor. The patient will be randomly placed into one of two groups. If the patient is in group A then they will continue with occupational therapy as normal. If the patient is assigned to group B then they and the family will have access to an activity cart found there in the ICU unit, directed by the nurses. The family will work with the patient on a daily basis to complete activities that are appropriate for the patient based on the occupational therapist's assessment. All patients in the study will receive medical care as usual.
Information about the patient's recovery in the hospital will be collected. In addition, patients and/or their family member will complete surveys at 6 months and 1 year after enrollment to see how they have recovered and if there are continuing issues. The two groups of patients, those who received the early cognitive training and those who did not, will be compared statistically to see if there are any differences in how well they recovered. Since this intervention involving family members working with the patient has not previously been evaluated, the study will also examine the feasibility of conducting these activities in the ICU setting.
This pilot study will assess the feasibility of implementing a randomized clinical trial testing an early cognitive training program for patients in the ICU. This cognitive training program was developed at Mount Carmel Health System in conjunction with occupational therapists and has not been previously evaluated.
Specific Aim 1: To evaluate whether the trial can accrue a sufficient number of patients within a reasonable time period to complete a randomized trial for efficacy.
Specific Aim 2: To evaluate whether the trial can be conducted as designed.
Specific Aim 3: To evaluate the likelihood that the trial can retain a sufficient number of patients through the end of follow-up.
Assessments include the Montreal Cognitive Assessment Test (MoCA), Richmond Agitation and Sedation Scale (RASS), Confusion Assessment Method in the ICU (CAM-ICU) and a validated quality of life survey.
Exclusion Criteria:
Usual medical care provided to patients in the ICU.
Usual medical care provided to patients in the ICU plus additional activities designed to engage the patient's attention and cognition. Activities are chosen by the family member from an activity cart according to the level designated by occupation therapy.
Behavioral: Early Cognitive Training
Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.
Percent Enrollment
Percent of eligible patients who are consented and enrolled into the study.
Time frame: 3 Days
Percent Receiving Intervention
Percent of patients randomized to intervention who receive intervention
Time frame: One month
Montreal Cognitive Assessment Score
Change in Montreal Cognitive Assessment score from baseline to 6 months
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No — No plans to share at this time. This intervention is being evaluated for feasibility.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Mount Carmel Health System