Study Stopped
Recruitment not sufficient to justify continuation
Speed of Processing Training for Cognitive Deficits After Delirium in Older Adults
2 other identifiers
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2020
CompletedNovember 16, 2021
November 1, 2021
1.8 years
November 10, 2017
November 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
General Cognitive Performance Battery
Composite Neuropsychological Test Battery
2 Month Follow-up
General Cognitive Performance Battery
Composite Neuropsychological Test Battery
24 Month Follow-up
Secondary Outcomes (4)
Timed Instrumental Activities of Daily Living
2 Month Follow-up
Timed Instrumental Activities of Daily Living
24 Month Follow-up
Incident Dementia
2 Month Follow-Up
Incident Dementia
24 Month Follow-Up
Study Arms (2)
Speed of Processing Training
EXPERIMENTALTraining 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.
Internet-Based Contact Control
ACTIVE COMPARATORTraining 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.
Interventions
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
This intervention provides social contact and mentally stimulating activities that do not target speed of processing
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Related Publications (2)
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.
PMID: 16731209BACKGROUNDInouye 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.
PMID: 27103261BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E Kennedy, MD, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2017
First Posted
November 17, 2017
Study Start
August 13, 2018
Primary Completion
May 31, 2020
Study Completion
May 31, 2020
Last Updated
November 16, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, 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.
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.