Early Cognitive Intervention in Delirium

Browse trials for

• Delirium 1,057
• Cognitive Dysfunction 3,842
• Dementia 2,172

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 283 is above the median of 120 across 599 interventional studies indexed under Delirium.

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Study arms

• Experimental
  Cognitive Intervention

  During hospitalization, enrolled patients assigned to the intervention arm will undergo two 20-minute cognitive training sessions daily, 7 days a week. After the patient is discharged from the hospital, cognitive rehabilitation will be administered once a week for 12-weeks at their place of residence. Goal Management Training will be the foundation for cognitive rehabilitation.

  Behavioral: Cognitive Training · Behavioral: Goal Management Training

• No intervention
  Usual Care

  Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.

Interventions

• BehavioralCognitive 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.

• BehavioralGoal 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.

Primary outcomes

1. Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

   A neuropsychological battery for global cognition which evaluates immediate and delayed memory, attention, visuospatial construction, and language. Scores range from 40 to 160, with higher scores indicating better cognition.

   Time frame: 4-months

Secondary outcomes

1. Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales

   The D-KEF's Proverbs, Color Word Interference, and Verbal Fluency Category Switching subscales will measure conceptual flexibility, inhibition, and monitoring, respecitvely, which encompasses the majority of executive function. The average of the three subscales will provide an executive function composite score. Scores range from 1 to 18 with higher values indicating better executive function

   Time frame: 4-months

2. Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale

   Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.

   Time frame: 4-months

3. Quality of Life as Measured by the EQ-5D-5L

   Characterizes quality of life and contains 5-dimensions ("5D") related to everyday living: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It asks patients to rate their current global health status from 0 (worst health you can imagine) to 100 (best health you can imagine). Scores range from -0.573 to 1.000 with higher scores indicating better quality of life.

   Time frame: 4-months

4. Vital Status (Dead / Alive)

   Death within 4-months will be recorded

   Time frame: 4-months

5. Nursing Home Placement (Yes / no)

   Nursing home placement within 4-months will be recorded

   Time frame: 4-months

6. Change in Montreal Cognitive Assessment

   Change in global cognition at 4-months compared to enrollment. The Montreal Cognitive Assessment assesses visuospatial, language, naming, memory, attention, abstraction, and orientation, and ranges from 0 to 30 (perfect cognition). It was collected at enrollment, during the delirium episode, and at 4 months.

   Time frame: 4-months

Baseline characteristics

Study documents

• Study protocol · Feb 4, 2022
• Statistical analysis plan · Nov 14, 2024
• Informed consent form · Apr 4, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Analytic code