NCT04740567

Early Cognitive Intervention in Delirium

Early Cognitive Training and Rehabilitation to Improve Long-term Cognitive Outcomes in Older Hospitalized Adults With Delirium

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 283 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized control trial to determine if early cognitive training and rehabilitation improve 4-month cognition in hospitalized older (\>=65 years old) delirious patients with and without Alzheimer's disease and related dementias. Enrolled patients will be randomized to receive cognitive intervention versus usual care at a 1:2 allocation ratio. Patients assigned to the cognitive intervention group will receive cognitive training daily during hospitalization and cognitive rehabilitation weekly for 12 weeks after hospital discharge. Patients will be evaluated for global cognition (primary outcome) and secondary outcomes at 4-months.

Conditions

• Delirium
• Cognitive Decline
• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Training	The cognitive training program regimen and its degree of difficulty will be tailored to the patient's current level of cognitive functioning and interests. Patients will be asked to work through progressively more challenging exercises pertaining to orientation, attention, problem-solving, and memory. These cognitive training exercises will be significantly difficult but when they can be completed easily (\>85% mastery), their difficulty will be increased, and this process will be repeated as appropriate. They will also perform puzzles, games, or cognitive tasks related to their hobbies.
BEHAVIORAL	Goal Management Training	Goal management training will (1) teach patients compensatory strategies such as "stop" techniques \[e.g., to "stop and think" about consequences of a decision before making it\]; (2) help them to take complex tasks and divide them into manageable subtasks to increase the likelihood of completing the task; and (3) enable them to learn to regain cognitive control when their behavior becomes incompatible with their intended goals. GMT is anchored in "sustained and vigilant attention theory" and it enables patients to actively attend to "higher order" goals critical to functioning. GMT is tailored to the individual needs of the patient. During the initial session, the Cognitive Intervention Specialist will meet with the subject and their family member or caregiver to identify these functional and cognitive deficiencies.

Timeline

• Start date: 2021-02-09
• Primary completion: 2024-11-14
• Completion: 2024-11-14
• First posted: 2021-02-05
• Last updated: 2025-12-24
• Results posted: 2025-12-24

Locations

2 sites across 1 country: United States