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Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03342989
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 18, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Richard Kennedy, University of Alabama at Birmingham

Brief Summary:
In this proposal, we will examine processing speed training (PST) as a potential intervention to reduce the risk of developing long-term cognitive impairment after a delirium episode.

Condition or disease Intervention/treatment Phase
Delirium Dementia Behavioral: Speed of Processing Training Behavioral: Internet-Based Contact Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 416 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults
Actual Study Start Date : August 13, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

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.
Behavioral: Speed of Processing Training
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.
Behavioral: Internet-Based Contact Control
This intervention provides social contact and mentally stimulating activities that do not target speed of processing




Primary Outcome Measures :
  1. General Cognitive Performance Battery [ Time Frame: 2 Month Follow-up ]
    Composite Neuropsychological Test Battery

  2. General Cognitive Performance Battery [ Time Frame: 24 Month Follow-up ]
    Composite Neuropsychological Test Battery


Secondary Outcome Measures :
  1. Timed Instrumental Activities of Daily Living [ Time Frame: 2 Month Follow-up ]
    Time to complete everyday activities

  2. Timed Instrumental Activities of Daily Living [ Time Frame: 24 Month Follow-up ]
    Time to complete everyday activities

  3. Incident Dementia [ Time Frame: 2 Month Follow-Up ]
    Time to Development of Dementia by Consensus Conference

  4. Incident Dementia [ Time Frame: 24 Month Follow-Up ]
    Time to Development of Dementia by Consensus Conference



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342989


Contacts
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Contact: Richard E Kennedy, MD, PhD 205-975-7563 rekenned@uab.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Richard E Kennedy, MD, PhD    205-975-7563    rekenned@uab.edu   
Principal Investigator: Richard E Kennedy, MD, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Richard E Kennedy, MD, PhD University of Alabama at Birmingham
Publications:
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Responsible Party: Richard Kennedy, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03342989    
Other Study ID Numbers: IRB-300000471
R21AG057982-01 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 18, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Given the current lack of treatments for the cognitive and functional complications of delirium, we anticipate that this data will be of great interest to other researchers, both for exploring additional hypotheses that were not part of this proposal and as pilot data for designing future trials of other interventions in delirium. Data to be shared will consist of demographic and medical data, cognitive assessment data, and data on daily functioning collected as part of the study. Data will be stripped of personal identifiers prior to distribution. Data will be made available by request through a secure file-sharing service hosted by the University of Alabama at Birmingham (e.g., UAB Box). Interview data will be made available in file formats for a variety of statistical software (e.g., SPSS, SAS, R). All investigators will provide instructions on how to access the data in any publications and presentations utilizing data from this proposal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Access to the data by other investigators, and dissemination of information on how to access the data, will begin as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, whichever is earlier.
Access Criteria: Data sets will be distributed to researchers at other institutions after approval by the study investigators. Researchers will be required to submit a data use agreement and a brief research proposal outlining the goals of the research and the specific data elements requested. All requests will also require IRB approval (or documentation of exemption from IRB review) by the researcher's institution prior to release as well as the UAB IRB.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Richard Kennedy, University of Alabama at Birmingham:
delirium
speed of processing
cognitive decline
Additional relevant MeSH terms:
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Delirium
Cognition Disorders
Cognitive Dysfunction
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations