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Boost Study 21270 (Cognition)

Primary Purpose

Cognitive Function Abnormal

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

mHealth application (custom)

About this trial

This is an interventional basic science trial for Cognitive Function Abnormal focused on measuring Cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Kansas State DPS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognition exercises group I

Cognition exercises group C

Arm Description

Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions

Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions

Outcomes

Primary Outcome Measures

Technical Feasibility (Task Completion)

Number of interaction trials completed (measured as whole number count, per subject, per week)

Secondary Outcome Measures

Task Performance

Baseline (Enrollment) and Postintervention (Week 8)

Usability Rating

DFS UX survey (assessed by Likert scale, 1-5 whole number response per question)

Full Information

NCT ID

NCT05990335

First Posted

July 31, 2023

Last Updated

August 11, 2023

Sponsor

NXTech

Collaborators

Kansas State University

1. Study Identification

Unique Protocol Identification Number

NCT05990335

Brief Title

Boost Study 21270 (Cognition)

Official Title

Mobile Software Application Intervention Including Cognitive Tasks

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 18, 2022 (Actual)

Primary Completion Date

March 15, 2023 (Actual)

Study Completion Date

March 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NXTech

Collaborators

Kansas State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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 for at least 150 min per week in app interaction activities for up to 8 weeks with measures primarily evaluating feasibility of app package task completion, and secondarily evaluating the cognitive effect of these activities.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Function Abnormal

Keywords

Cognition

7. Study Design

Primary Purpose

Basic Science

Study Phase

Early Phase 1

Interventional Study Model

Factorial Assignment

Model Description

Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cognition exercises group I

Arm Type

Experimental

Arm Description

Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions

Arm Title

Cognition exercises group C

Arm Type

Active Comparator

Arm Description

Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions

Intervention Type

Behavioral

Intervention Name(s)

mHealth application (custom)

Intervention Description

Smartphone based application designed to engage user executive functions

Primary Outcome Measure Information:

Title

Technical Feasibility (Task Completion)

Description

Number of interaction trials completed (measured as whole number count, per subject, per week)

Time Frame

Weekly, for 8 weeks

Secondary Outcome Measure Information:

Title

Task Performance

Description

Baseline (Enrollment) and Postintervention (Week 8)

Time Frame

Weekly, for 8 weeks

Title

Usability Rating

Description

DFS UX survey (assessed by Likert scale, 1-5 whole number response per question)

Time Frame

Once, at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Travis Smith

Organizational Affiliation

Kansas State

Official's Role

Study Director

Facility Information:

Facility Name

Kansas State DPS

City

Manhattan

State/Province

Kansas

ZIP/Postal Code

66506

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Boost Study 21270 (Cognition)

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