- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03342989
Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
The overall goal of this project is to measure longitudinal cognitive function among hospitalized older adults after an episode of delirium, and examine an intervention (processing speed training, or PST) to slow the rate of cognitive decline that occurs after an episode of delirium compared to an Internet-based control condition (INT). We will initially recruit a cohort of 136 subjects who have experienced delirium, provide PST or INT training to them, and assess them on measures of cognition and instrumental activities of daily living (IADLs) after training and every 6 months thereafter for 24 to 36 months. We will perform a preliminary determination of the efficacy of PST after these 136 subjects have completed training, testing whether subjects receiving PST have better cognitive test scores immediately after training compared to subjects receiving INT. Assuming this preliminary test of efficacy shows short-term benefits for PST, we will recruit an additional 280 subjects who have experienced delirium and provide PST training to them. We will follow all 416 subjects for 24 to 36 months after their delirium episode to test whether subjects receiving PST have slower rates of decline over time compared to subjects receiving INT on measures of cognition and IADLs. A more detailed timeline of study procedures follows.
In Hospital (Month 0): We will initially identify subjects with delirium from the inpatient medical units at UAB Hospital. As part of UAB's Virtual ACE quality improvement project, nurses on the medical units administer the Nursing Delirium Screening Scale (NUDESC) to screen for delirium in all patients age ≥ 65 on admission and once per shift thereafter. After obtaining informed consent, we will collect a range of measures from the subject and family to make the diagnosis of delirium and rate its severity, as well as measures examining comorbidities potentially contributing to delirium. These measures for assessing delirium will be
- the NUDESC ratings from the medical record;
- the Confusion Assessment Method (CAM), a standard clinician-rated instrument for the diagnosis of delirium;
- the Delirium Symptom Interview (DSI), an interview administered by a clinician to standardize the assessment of delirium symptoms for rating the CAM;
- the Cognitive Test for Delirium (CTD), a general measure of cognition used to standardize the assessment of cognitive symptoms for rating the CAM;
- the Family Confusion Assessment Method (FAMCAM), which assesses the family's observation of symptoms of delirium (although this will not be required for delirium diagnosis);
- the chart-based review method for delirium (CHART-DEL), which collects information from the medical records about signs and symptoms that can indicate delirium;
- the Delirium Etiology Rating Checklist (DERC), a clinician-rated instrument that categorizes the different potential causes of delirium for the subject, based on information in the medical record on other medical conditions, current medications, neuroimaging (CT or MRI, if available), abnormal laboratory values (complete blood count, serum electrolytes and chemistries, liver function tests, and urine drug screen, if available);
- the Anticholinergic Burden Scale (ABS), which rates the contribution of the subject's medications to their episode of delirium.
Additional measures collected on comorbidities and factors affecting delirium will be
- demographics (age, race, gender);
- the AD8 and the Modified Blessed Dementia Rating Scale, which assess the family's observations of symptoms of dementia that preceded the episode of delirium;
- the Charlson Comorbidity Index (CCI), which assesses the presence of other medical conditions beyond delirium.
After the initial in-hospital assessment, we will continue to follow the subject for the remainder of their stay, using the CAM and the DRS-R-98 to monitor the duration of delirium. We will also collect the NUDESC assessments given by nursing staff on a daily basis.
Outpatient Baseline (Approximately Month 1, depending on length of hospitalization): Approximately 2 weeks after hospital discharge, we will contact subjects by telephone for follow-up. We will review the study procedures with the subject and use the CAM to see if their delirium has resolved. Once a subject's delirium has resolved, we will bring them to our offices for a comprehensive baseline assessment. Measures for this visit will examine cognition (particularly memory and executive function) and function (particularly activities of daily living and instrumental activities of daily living), as well as general health and mental health. Specific measures will be
- the CAM;
- the FAMCAM;
- the CTD;
- the AD8;
- the Wechsler Test of Adult Reading (WTAR), a vocabulary test to estimate IQ;
the General Cognitive Performance (GCP) battery, a composite of the following neuropsychological tests
- the Visual Search and Attention Test, measuring executive function and visuospatial skills;
- the Hopkins Verbal Learning Test-Revised, measuring verbal memory;
- the WAIS Digit Span Forward and Backward, measuring attention;
- Category Fluency, measuring executive function and language;
- Phonemic Fluency, measuring executive function and language;
- the Boston Naming Test, measuring naming and language;
- the RBANS Digit Symbol Test, measuring executive function and visuospatial skills;
- the DKEFS Trail Making Test, measuring executive function and visuospatial skills;
- the Katz Activities of Daily Living (ADLs), which rates ability to perform basic activities for daily life;
- the Lawton Instrumental Activities of Daily Living (IADLs), which rates ability to perform more complex activities for daily life;
- the Timed IADLs, which measures speed at performing complex activities of daily life;
- the Geriatric Depression Scale (GDS), a standard measure of depressive symptoms in older adults;
- the Medical Outcomes Study 12-item Short Form (SF-12), a standard measure of overall health and quality of life;
- healthcare utilization (rehospitalization or institutionalization) since discharge.
PST or INT Training (Months 1 and 2): After the baseline assessment, we will randomize each subject to 10 sessions of PST or INT, which will be conducted in the outpatient setting at UAB for standardization. The PST training consists of computer-administered sessions in which a subject practices detection and discrimination of targets displayed for short periods of time. The INT training consists of sessions in which a subject practices general computer skills and use of Internet search engines.
Post-Training Assessment (Month 2): After lab-based training, subjects will complete a follow-up assessment that will repeat measures of cognition, function, and general health
- the GCP (neuropsychological testing);
- the Katz ADLs (functional status);
- the Lawton IADLs (functional status);
- the Timed IADLs (functional status);
- the GDS (mental health);
- the SF-12 (general health);
- the AD8 (dementia symptoms);
- healthcare utilization (rehosopitalization or institutionalization) since baseline.
Semiannual Assessments (Months 6, 12, 18, 24, 30, and 36): Subjects will continue to practice PST or INT at home with study-distributed tablet computers and supportive visits for the remainder of the study. Every 6 months, we will repeat measures of cognition, function, and general health
- the GCP (neuropsychological testing);
- the Katz ADLs (functional status);
- the Lawton IADLs (functional status);
- the Timed IADLs (functional status);
- the GDS (mental health);
- the SF-12 (general health);
- the AD8 (dementia symptoms AD8);
- healthcare utilization (rehospitalization or institutionalization) since previous visit;
- incident dementia.
For the determination of incident dementia, data on subjects scoring more than 1 standard deviation below the mean on 2 or more neuropsychological tests will be reviewed by a Clinical Consensus Panel, who will assign a diagnosis of mild cognitive impairment or dementia (if warranted) according to National Institute on Aging-Alzheimer's Association criteria.
Preliminary Evaluation of Short-Term Treatment Efficacy This evaluation will be examine short-term differences between groups on cognition (GCP) and function (Timed IADLs) at 2 months, after all 136 subjects have completed lab-based PST or INT training. We will also evaluate the effects of pre-existing cognitive impairment by comparing the effects of PST to those without pre-existing cognitive impairment. Using ANOVA to compare treatment groups, a sample size of N=136 will have greater than 80% power to detect a 30% difference in scores on the GCP, which is smaller than the 30% difference considered meaningful in trials for interventions in prodromal Alzheimer's disease. A sample size of N=136 will also be sufficient to allow comparisons between subjects with and without pre-existing cognitive impairment.
Recruitment of the Second Cohort Assuming the preliminary evaluation of treatment efficacy demonstrates positive effects for PST, we recruit 280 additional subjects while continuing to follow the original cohort of 136 subjects, so that our total cohort of 416 subjects will provide sufficient power to examine the effect of PST on cognitive and functional declines over time. Enrollment procedures and assessments for new subjects will be identical to those for the original cohort. After completion of PST or INT training, all subjects will be followed for 24 to 36 months (depending on the time of enrollment), with assessments every 6 months as described above.
Evaluation of Long-Term Treatment Efficacy We will evaluate efficacy by examining differences in the slope, or rate of change, on cognition (the GCP) and function (Timed IADLs) between the PST and INT groups over the follow-up period. We will also evaluate whether effects of PST on cognitive outcomes differs subjects with pre-existing MCI or mild dementia compared to those without pre-existing cognitive impairment. Using mixed effects models to compare slopes, a sample size of N=416 will have greater than 80% power to detect a difference between treatment groups. This will also be sufficient to allow comparisons between subjects with and without pre-existing cognitive impairment.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- English speaking (English need not be first language);
- admission to the inpatient medical wards at University of Alabama at Birmingham Hospital;
- positive screen for delirium, defined as a score ≥ 1 on the Nursing Delirium Screening Scale, during hospitalization;
- presence of delirium, defined using the Confusion Assessment Method, during hospitalization;
- informant-rated AD8 score ≤ 6;
- living within 40 miles of the Birmingham, Alabama metro area.
Exclusion Criteria:
- active delirium at the time of baseline assessment after hospital discharge, defined using the Confusion Assessment Method;
- hospitalization in the previous 3 months prior to the index hospitalization;
- terminal condition with life expectancy < 6 months;
- inability to perform cognitive tests due to poor vision or hearing at baseline assessment;
- history of schizophrenia or other psychotic disorder;
- alcohol withdrawal delirium during hospitalization, history of alcohol abuse, or history of alcohol withdrawal in the previous 6 months;
- unable to provide informed consent at baseline visit (proxy consent may be used for in-hospital assessments).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Speed of Processing Training
Training involves detection, localization, and discrimination of briefly displayed stimuli (17-500 milliseconds) using tasks with varying demands on visual attention.
Cognitive processing speed is defined as response accuracy at a given display duration, regardless of motor speed.
Training involves detection, localization, and discrimination of briefly displayed stimuli (17-500 milliseconds) using tasks with varying demands on visual attention.
Speed of processing is defined as response accuracy at a given display duration, regardless of motor speed.
Training consists of 10 lab-based sessions over 5 weeks, followed by home-based practice on a tablet computer for 24 months with supportive home visits.
|
This intervention is based on computer-administered tasks that are used to evaluate Useful Field of View test, which measures discrimination between visually presented stimuli in the presence of distractors
|
Active Comparator: Internet-Based Contact Control
Training involves mentally stimulating activity and consists of three levels: (1) using a computer (e.g., mouse training, pull-down menus, selecting options), (2) internet search engine training, and (3) search engine proficiency tasks.
Training consists of 10 lab-based sessions over 5 weeks, followed by home-based practice on a tablet computer for 24 months with supportive home visits.
|
This intervention provides social contact and mentally stimulating activities that do not target speed of processing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
General Cognitive Performance Battery
Time Frame: 2 Month Follow-up
|
Composite Neuropsychological Test Battery
|
2 Month Follow-up
|
General Cognitive Performance Battery
Time Frame: 24 Month Follow-up
|
Composite Neuropsychological Test Battery
|
24 Month Follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timed Instrumental Activities of Daily Living
Time Frame: 2 Month Follow-up
|
Time to complete everyday activities
|
2 Month Follow-up
|
Timed Instrumental Activities of Daily Living
Time Frame: 24 Month Follow-up
|
Time to complete everyday activities
|
24 Month Follow-up
|
Incident Dementia
Time Frame: 2 Month Follow-Up
|
Time to Development of Dementia by Consensus Conference
|
2 Month Follow-Up
|
Incident Dementia
Time Frame: 24 Month Follow-Up
|
Time to Development of Dementia by Consensus Conference
|
24 Month Follow-Up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard E Kennedy, MD, PhD, University of Alabama at Birmingham
Publications and helpful links
General Publications
- Inouye SK, Marcantonio ER, Kosar CM, Tommet D, Schmitt EM, Travison TG, Saczynski JS, Ngo LH, Alsop DC, Jones RN. The short-term and long-term relationship between delirium and cognitive trajectory in older surgical patients. Alzheimers Dement. 2016 Jul;12(7):766-75. doi: 10.1016/j.jalz.2016.03.005. Epub 2016 Apr 18.
- Wadley VG, Benz RL, Ball KK, Roenker DL, Edwards JD, Vance DE. Development and evaluation of home-based speed-of-processing training for older adults. Arch Phys Med Rehabil. 2006 Jun;87(6):757-63. doi: 10.1016/j.apmr.2006.02.027.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-300000471
- R21AG057982-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Delirium
-
Efficacy Care R&D LtdHadassah Medical OrganizationUnknownDelirium | Delirium, Cause Unknown | Delirium of Mixed Origin | Delirium Confusional State | Delirium Drug-InducedIsrael
-
Imperial College Healthcare NHS TrustRecruitingCardiac Surgery | Intensive Care Unit Delirium | Post Operative DeliriumUnited Kingdom
-
Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicRecruitingDelirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional StateNorway
-
Menoufia UniversityCompleted
-
Universidad de SantanderUnknownDelirium of Mixed Origin | Hypoactive Delirium | Hyperactive DeliriumColombia
-
Johns Hopkins UniversityNational Institute on Aging (NIA)Active, not recruitingDelirium | Delirium on Emergence | Hearing Loss | Hearing Loss, High-Frequency | Hearing Loss, Sensorineural | Delirium, Cause Unknown | Hearing Loss, Bilateral | Hearing Disability | Delirium in Old Age | Delirium of Mixed Origin | Delirium Superimposed on Dementia | Delirium Confusional State | Delirium With... and other conditionsUnited States
-
Chinese PLA General HospitalBeijing Tiantan HospitalRecruiting
-
Charite University, Berlin, GermanyBARMERRecruitingDelirium in Old AgeGermany
-
Mayo ClinicCompletedPost-Operative DeliriumUnited States
-
University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRecruitingPostoperative Delirium (POD)Switzerland
Clinical Trials on Speed of Processing Training
-
Kessler FoundationNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Kessler FoundationCompletedTraumatic Brain Injury | Mild Cognitive ImpairmentUnited States
-
Indiana UniversityCompleted
-
Kessler FoundationNational Multiple Sclerosis SocietyCompletedMultiple SclerosisUnited States
-
Hartford HospitalNational Institute of Mental Health (NIMH)Completed
-
University of RochesterNational Institute of Nursing Research (NINR)CompletedMild Cognitive ImpairmentUnited States
-
University of Alabama at BirminghamRecruiting
-
University of Alabama at BirminghamCompletedHIV | Impaired Driving | Cognition - OtherUnited States
-
University of Alabama at BirminghamNational Institute on Aging (NIA)CompletedParkinson's DiseaseUnited States
-
Portucalense UniversityUniversity of Coimbra; Aveiro UniversityRecruitingCognitive Dysfunction | Mild Cognitive Impairment | Cognitive Training | tACSPortugal