Boost Study 21270 (Cognition)

December 15, 2024 updated by: NXTech

Mobile Software Application Intervention Including Cognitive Tasks

This study is designed to to test the technical feasibility of encouraging interaction with a mobile smartphone software package (mHealth app) for training aspects of executive function and cognition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this human subjects study is to test the technical feasibility of interaction with a mobile smartphone software package (mHealth app) for training in aspects of executive function and cognition. The study participants are healthy subjects recruited online, with consent secured at the time of screening, and with enrollees assigned to High or Low groups on the basis of initial screening task scores. Subjects are requested to participate in directed interaction activities for up to 8 weeks, with measures primarily evaluating feasibility of MHealth app package task completion and secondarily evaluating the cognitive effect of activities.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Early Phase 1

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

  • United States
    • Kansas
      • Manhattan, Kansas, United States, 66506
        • Kansas State DPS

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age 18 years and above
  • Fluent in English
  • Resides in the United States
  • Score on prescreen task is in 25% quartile
  • Familiar with smartphone device app installation and device usage
  • Possesses a compatible smartphone

Exclusion Criteria:

None

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cognition exercises group I
Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions
Behavioral: mHealth application (custom)
Smartphone based application designed to engage user executive functions
Active Comparator: Cognition exercises group C
Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions
Behavioral: mHealth application (custom)
Smartphone based application designed to engage user executive functions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Task Completion Rate
Time Frame: At 8 weeks
Percentage of participants completing minimum required weekly interactions
At 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Task Performance
Time Frame: At 8 weeks
Change in Human Hypothetical Choice scale (higher scores indicate a better outcome, minimum value 0 to maximum value 1), calculated as value at 8 weeks minus value at 1 week
At 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NXTech

Collaborators

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)
Kansas State University

Investigators

  • Study Director: Travis Smith, Kansas State

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)

April 18, 2022

Primary Completion (Actual)

March 27, 2023

Study Completion (Actual)

March 27, 2023

Study Registration Dates

First Submitted

July 31, 2023

First Submitted That Met QC Criteria

August 5, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 15, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NX-21270
  • R43DA051270 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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