Pilot Study of Early Cognitive Training in the Intensive Care Unit

NCT03284437 | Withdrawn

• 1 other identifier: 170214-3
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Intensive Care Units, Delirium, Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• Percent Enrollment

  Percent of eligible patients who are consented and enrolled into the study.

  3 Days

• Percent Receiving Intervention

  Percent of patients randomized to intervention who receive intervention

  One month

Secondary Outcomes (1)

• Montreal Cognitive Assessment Score

  6 months

Study Arms (2)

Usual Care

NO INTERVENTION

Usual medical care provided to patients in the ICU.

Early Cognitive Training

EXPERIMENTAL

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

Interventions

Early Cognitive Training BEHAVIORAL

Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.

Early Cognitive Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be in the intensive care unit, i.e., either the surgical intensive care unit (SICU) or medical intensive care unit (MICU).
• Patient must be ≥18 years old.
• Predicted ICU length of stay greater than 3 days.
• Patient with a RASS goal of -1 to +1 at time of enrollment.
• Patient's family member(s) agree to do the cognitive training for a least one hour a day (a series of items meant to focus and stretch cognitive ability) while in the ICU. The hour can be done incrementally if needed. Family member should be ≥18 years old.
• Family who can return to the hospital at the 6 month mark to take a final MOCA test and complete a survey.

You may not qualify if:

• Patient presently on Versed, Diprivan or Ativan drips.
• Patient with a history of cognitive impairment, current psychiatric diagnosis and not stable on treatment, or developmental delay.
• Patient with Alzheimer's or dementia.
• Patient with known active substance abuse.
• Patients without family support.
• Patients without the ability to return to the hospital for the 6 month visit.
• Patient with history of critical care illness within the last year from time of enrollment.
• Patients who have been critically ill for greater than 72 hours.
• Non-English speaking individuals restricting ability to follow instructions

Sponsors & Collaborators

• Mount Carmel Health System: lead

MeSH Terms

Conditions

Delirium; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Terri Swan, BSN

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor is not participating in patient enrollment or administration of study intervention and will not be aware of study group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 15, 2017
• Study Start: January 5, 2021
• Primary Completion: April 26, 2021
• Study Completion: April 26, 2021
• Last Updated: November 27, 2024

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share