- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195230
Cognitive Multi-Tasking Training in Healthy Older Adults
February 25, 2022 updated by: Columbia University
Cognitive Training in a Multi-task Daily Life Task: a Feasibility Study in Healthy Older Adults
This study evaluated the feasibility of a remote web-based ecological cognitive training protocol to healthy older adults.
The training protocol involves 5 training sessions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous research demonstrated the relevance in training cognitive abilities that typically decline with age, such as those associated with executive control (e.g., abstract thinking, selective and divided attention, planning, task-switching and inhibitory control).
The aim of the present study is to investigate the feasibility of a web-based cognitive training focused on executive control to cognitively healthy older adults.
The participants will undergo the web-training in a daily type situation of meal preparation (i.e., Breakfast Game).
The training protocol combines the tasks of table setting and cooking in a multi-tasking fashion.
In some sessions Emphasis Change approach will be apply to the training, in order to assess it feasibility and potential effects in optimizing the performance.
In addition, participants will undergo a brief web-based cognitive evaluation before and after training.
If feasible, the investigators protocol will allow training older adults in critical cognitive skills for daily life situations.
The web-based training is an advancement since it can be delivered at-home, remotely supervised, and is easily scalable.
Recently, remote interventions have been particularly relevant to older adults due to the COVID-19 pandemic, which may limit in-person research participation.
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10032
- Columbia University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Cognitively healthy older adults
Exclusion Criteria:
- Low test scores (below 26 on the Montreal Cognitive Assessment - MoCA)
- Presence of certain medical conditions (i.e., major neurological or psychiatric disorder, or a medical condition that may impact cognitive functioning).
- Subjects which English is not the primary language, or with lack of capacity to consent will not be enrolled.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Computerized Cognitive Training (Breakfast Game)
Participants will undergo a pilot training protocol where they will have to perform two tasks concomitantly, in a multi-tasking fashion.
The tasks are related to everyday activities as "cooking" and "setting tables".
|
Participants will undergo training protocol where they will have, concomitantly, to cook different meals and set the table under different instructions, rules and difficulty level.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Cooking Time Discrepancy Scores
Time Frame: Up to 3 weeks
|
Change in cooking time (milliseconds) in each food type.
In the computerized task, participants are asked to cook different food types.
Scores reflect the average absolute values of the difference between the required and actual cooking time of each item.
Lowers scores (closest to zero) represent a better outcome.
|
Up to 3 weeks
|
Change in Range of Stop Times Score
Time Frame: Up to 3 weeks
|
Change in cooking time (milliseconds) between food items.
In the computerized task, participants are asked to cook different food types.
Scores reflect is the difference between the first and last food item stopped cooking.
Lowers scores (closest to zero) represent a better outcome.
|
Up to 3 weeks
|
Change in the Number of Tables Set Score
Time Frame: Up to 3 weeks
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Change in the total number of tables set.
In the computerized task, participants are asked to set tables for four guests, when finished, one point is given.
Higher scores represent a better outcome.
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Up to 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-training feasibility questionnaire
Time Frame: Within one week after the intervention
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Questionnaire assessing participant´s opinions about performing the web-based training based on Breakfast Game (e.g., difficulty, satisfaction).
Higher scores reflect feasibility of the intervention.
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Within one week after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yaakov Stern, Ph.D., Columbia University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2020
Primary Completion (Actual)
November 5, 2021
Study Completion (Actual)
November 5, 2021
Study Registration Dates
First Submitted
December 9, 2019
First Submitted That Met QC Criteria
December 10, 2019
First Posted (Actual)
December 11, 2019
Study Record Updates
Last Update Posted (Actual)
February 28, 2022
Last Update Submitted That Met QC Criteria
February 25, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAS6529
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified individual participant data for all primary and secondary outcome measures will be made available.
IPD Sharing Time Frame
Data will be available within 6 months of study completion.
IPD Sharing Access Criteria
Data access requests will be reviewed by the principal investigator.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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