NCT04195230

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

January 2, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2021

Completed
Last Updated

February 28, 2022

Status Verified

February 1, 2022

Enrollment Period

1.8 years

First QC Date

December 9, 2019

Last Update Submit

February 25, 2022

Conditions

Keywords

Web-based Cognitive TrainingExecutive FunctionsAttentionMulti-taskingAgingHealthy Adults

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Up to 3 weeks

Secondary Outcomes (1)

  • Post-training feasibility questionnaire

    Within one week after the intervention

Study Arms (1)

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".

Behavioral: Multi-tasking Training

Interventions

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.

Computerized Cognitive Training (Breakfast Game)

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cognitively healthy older adults

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Yaakov Stern, Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2019

First Posted

December 11, 2019

Study Start

January 2, 2020

Primary Completion

November 5, 2021

Study Completion

November 5, 2021

Last Updated

February 28, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
Data will be available within 6 months of study completion.
Access Criteria
Data access requests will be reviewed by the principal investigator.

Locations