Age-related Cognitive DeclineNCT04195230
Cognitive Multi-Tasking Training in Healthy Older Adults
A study testing Multi-tasking Training in people with Age-related Cognitive Decline, run by Columbia University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- Multi-tasking Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2020to 5 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cognitively healthy older adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Age-related Cognitive Decline
- Being tested
- Multi-tasking Training
- Keywords
- Web-based Cognitive Training, Executive Functions, Attention, Multi-tasking, Aging, Healthy Adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-tasking TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training (Breakfast Game) | Experimental | 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". Receives: Behavioral: Multi-tasking Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cooking Time Discrepancy Scores
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.
Measured: Up to 3 weeks
Change in Range of Stop Times Score
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.
Measured: Up to 3 weeks
Change in the Number of Tables Set Score
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.
Measured: Up to 3 weeks
Secondary outcomes (1)
Post-training feasibility questionnaire
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.
Measured: Within one week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start2 Jan 2020
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Age-related Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yaakov Stern, Ph.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04195230
- Sponsor's protocol ID
- AAAS6529
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2019
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Publications
Sanz Simon S, Ben-Eliezer D, Pondikos M, Stern Y, Gopher D. Feasibility and acceptability of a new web-based cognitive training platform for cognitively healthy older adults: the breakfast task. Pilot Feasibility Stud. 2023 Aug 4;9(1):136. doi: 10.1186/s40814-023-01359-2.
PubMed 37542331
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in a Multi-task Daily Life Task: a Feasibility Study in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04195230
- Acronym / sponsor ID
- AAAS6529
- Conditions
- Age-related Cognitive Decline
- Keywords
- Web-based Cognitive Training, Executive Functions, Attention, Multi-tasking, Aging, Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 11 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training (Breakfast Game) | Experimental | Behavioral: Multi-tasking TrainingParticipants 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". |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Cognitively healthy older adults
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-tasking TrainingParticipants will undergo training protocol where they will have, concomitantly, to cook different meals and set the table under different instructions, rules and difficulty level. | Behavioural | Computerized Cognitive Training (Breakfast Game) |
Primary outcome
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.
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.
Change in the Number of Tables Set Score
Time frame: Up to 3 weeks
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.
1 secondary outcome
Post-training feasibility questionnaire
Time frame: Within one week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Derived from this study: PubMed 37542331Sanz Simon S, Ben-Eliezer D, Pondikos M, Stern Y, Gopher D. Feasibility and acceptability of a new web-based cognitive training platform for cognitively healthy older adults: the breakfast task. Pilot Feasibility Stud. 2023 Aug 4;9(1):136. doi: 10.1186/s40814-023-01359-2.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaakov Stern, Ph.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-tasking Training in people with Age-related Cognitive Decline, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cooking Time Discrepancy Scores (time frame: Up to 3 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04195230, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.