Delirium, Cognitive Decline, Dementia
Conditions
Brief 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.
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.
Sponsors
National Institute on Aging (NIA)
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years or older * Admitted through the ED * Cognitive training can be initiated within 24 hours of ED presentation * Delirious at enrollment
Exclusion criteria
* Comatose * Not able to follow simple commands or non-verbal prior to the acute illness (end-stage pre-illness ADRD) * Resides in a nursing home * Prisoner * Receiving hospice care * Lives \> 100 miles away from the enrolling sites * Non-English speaking * Previously enrolled * Deaf or blind * Intravenous drug, crack or cocaine, or methamphetamine use within the past one year, or any condition that, in the investigator's opinion, makes them an unreliable trial patient or unlikely to complete the trial. * Psychotic disorder or suicidal gesture requiring hospitalization with the past one year * Discharged from the ED
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 4-months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale | 4-months | Characterizes seven basic and seven instrumental activities of daily living. Scores range from 0 to 28 with higher scores indicating better functional status. |
| Quality of Life as Measured by the EQ-5D-5L | 4-months | 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. |
| Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales | 4-months | 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 |
| Nursing Home Placement (Yes / no) | 4-months | Nursing home placement within 4-months will be recorded |
| Change in Montreal Cognitive Assessment | 4-months | 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. |
| Vital Status (Dead / Alive) | 4-months | Death within 4-months will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 97 |
| Usual Care Enrolled patients will undergo usual care during hospitalization and post-hospital discharge. | 186 |
| Total | 283 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 31 | 43 |
| Overall Study | Lost to Follow-up | 2 | 11 |
| Overall Study | Patient declined to participate | 13 | 26 |
| Overall Study | Patient's spouse was had prolongued ICU stay | 0 | 1 |
| Overall Study | Patient was physically incapable | 1 | 3 |
Baseline characteristics
| Characteristic | Cognitive Intervention | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 97 Participants | 186 Participants | 283 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 76 years | 75 years | 75 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 27 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 81 Participants | 154 Participants | 235 Participants |
| Sex: Female, Male Female | 42 Participants | 89 Participants | 131 Participants |
| Sex: Female, Male Male | 55 Participants | 97 Participants | 152 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 31 / 97 | 43 / 186 |
| other Total, other adverse events | 0 / 97 | 0 / 186 |
| serious Total, serious adverse events | 0 / 97 | 0 / 186 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Intervention | Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 67 score on a scale |
| Usual Care | Global Cognition as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | 67 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Intervention | Change in Montreal Cognitive Assessment | 3.5 score on a scale |
| Usual Care | Change in Montreal Cognitive Assessment | 4 score on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Intervention | Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales | 5.5 score on a scale |
| Usual Care | Executive Function as Measured by the Components of the Delis-Kaplan Executive Function System (D-KEFS) Subscales | 4.0 score on a scale |
Secondary
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
Population: Patient surrogates were able to complete this assessment which is why the total N is higher than the total number with completed outcomes.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Intervention | Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale | 9 score on a scale |
| Usual Care | Functional Status as Measured by Older American Resources and Services Activities of Daily Living Scale | 8 score on a scale |
Secondary
Nursing Home Placement (Yes / no)
Nursing home placement within 4-months will be recorded
Time frame: 4-months
Population: All patients who were randomized included in the nursing home analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Intervention | Nursing Home Placement (Yes / no) | 2 Participants |
| Usual Care | Nursing Home Placement (Yes / no) | 2 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cognitive Intervention | Quality of Life as Measured by the EQ-5D-5L | 0.352 score on a scale |
| Usual Care | Quality of Life as Measured by the EQ-5D-5L | 0.269 score on a scale |
Secondary
Vital Status (Dead / Alive)
Death within 4-months will be recorded
Time frame: 4-months
Population: All patients who were randomized were included in the mortality outcome analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cognitive Intervention | Vital Status (Dead / Alive) | 31 Participants |
| Usual Care | Vital Status (Dead / Alive) | 43 Participants |