Trial Outcomes & Findings for Early Cognitive Intervention in Delirium (NCT NCT04740567)
NCT ID: NCT04740567
Last Updated: 2025-12-24
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
283 participants
Primary outcome timeframe
4-months
Results posted on
2025-12-24
Participant Flow
Participant milestones
| Measure |
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
|
Usual Care
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Overall Study
STARTED
|
97
|
186
|
|
Overall Study
COMPLETED
|
50
|
102
|
|
Overall Study
NOT COMPLETED
|
47
|
84
|
Reasons for withdrawal
| Measure |
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
|
Usual Care
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Overall Study
Death
|
31
|
43
|
|
Overall Study
Lost to Follow-up
|
2
|
11
|
|
Overall Study
Patient declined to participate
|
13
|
26
|
|
Overall Study
Patient was physically incapable
|
1
|
3
|
|
Overall Study
Patient's spouse was had prolongued ICU stay
|
0
|
1
|
Baseline Characteristics
Early Cognitive Intervention in Delirium
Baseline characteristics by cohort
| Measure |
Cognitive Intervention
n=97 Participants
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.
|
Usual Care
n=186 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Age, Categorical
>=65 years
|
97 Participants
n=30 Participants
|
186 Participants
n=30 Participants
|
283 Participants
n=60 Participants
|
|
Age, Continuous
|
76 years
n=30 Participants
|
75 years
n=30 Participants
|
75 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=30 Participants
|
89 Participants
n=30 Participants
|
131 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=30 Participants
|
97 Participants
n=30 Participants
|
152 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=30 Participants
|
27 Participants
n=30 Participants
|
41 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
81 Participants
n=30 Participants
|
154 Participants
n=30 Participants
|
235 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=30 Participants
|
2 Participants
n=30 Participants
|
3 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
1 Participants
n=30 Participants
|
1 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: 4-monthsA 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.
Outcome measures
| Measure |
Cognitive Intervention
n=50 Participants
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.
|
Usual Care
n=102 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
67 score on a scale
Interval 49.0 to 80.0
|
67 score on a scale
Interval 52.0 to 83.0
|
SECONDARY outcome
Timeframe: 4-monthsThe 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
Outcome measures
| Measure |
Cognitive Intervention
n=32 Participants
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.
|
Usual Care
n=72 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales
|
5.5 score on a scale
Interval 3.0 to 8.0
|
4.0 score on a scale
Interval 0.0 to 11.0
|
SECONDARY outcome
Timeframe: 4-monthsPopulation: Patient surrogates were able to complete this assessment which is why the total N is higher than the total number with completed outcomes.
Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status.
Outcome measures
| Measure |
Cognitive Intervention
n=54 Participants
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.
|
Usual Care
n=117 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale
|
9 score on a scale
Interval 2.0 to 16.0
|
8 score on a scale
Interval 3.0 to 13.0
|
SECONDARY outcome
Timeframe: 4-monthsCharacterizes 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.
Outcome measures
| Measure |
Cognitive Intervention
n=49 Participants
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.
|
Usual Care
n=96 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Quality of Life as Measured by the EQ-5D-5L
|
0.352 score on a scale
Interval 0.096 to 0.727
|
0.269 score on a scale
Interval 0.096 to 0.465
|
SECONDARY outcome
Timeframe: 4-monthsPopulation: All patients who were randomized were included in the mortality outcome analysis.
Death within 4-months will be recorded
Outcome measures
| Measure |
Cognitive Intervention
n=97 Participants
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.
|
Usual Care
n=186 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Vital Status (Dead / Alive)
|
31 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: 4-monthsPopulation: All patients who were randomized included in the nursing home analysis.
Nursing home placement within 4-months will be recorded
Outcome measures
| Measure |
Cognitive Intervention
n=97 Participants
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.
|
Usual Care
n=186 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Nursing Home Placement (Yes / no)
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 4-monthsChange 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.
Outcome measures
| Measure |
Cognitive Intervention
n=40 Participants
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.
|
Usual Care
n=85 Participants
Enrolled patients will undergo usual care during hospitalization and post-hospital discharge.
|
|---|---|---|
|
Change in Montreal Cognitive Assessment
|
3.5 score on a scale
Interval 0.0 to 6.5
|
4 score on a scale
Interval 0.0 to 11.0
|
Adverse Events
Cognitive Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 31 deaths
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 43 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place