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Pilot Study of Early Cognitive Training in the Intensive Care Unit

Launched by MOUNT CARMEL HEALTH SYSTEM · Sep 14, 2017

Trial Information

Current as of June 08, 2025

Withdrawn

Keywords

ClinConnect Summary

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 lik...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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

About Mount Carmel Health System

Mount Carmel Health System is a comprehensive healthcare provider based in Central Ohio, dedicated to delivering high-quality medical services and advancing clinical research. With a commitment to patient-centered care, Mount Carmel integrates innovative clinical trials into its extensive range of services, aiming to improve health outcomes and contribute to the advancement of medical knowledge. The system collaborates with leading researchers and institutions to conduct trials across various specialties, ensuring rigorous adherence to ethical standards and regulatory compliance. Through its focus on research and development, Mount Carmel Health System strives to enhance therapeutic options and improve the overall well-being of the communities it serves.

Locations

Patients applied

0 patients applied

Trial Officials

Terri Swan, BSN

Principal Investigator

Mount Carmel Health System

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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