Boost Study 21270 (Cognition)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mobile Software Application Intervention Including Cognitive Tasks

Conditions
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Cognitive Function Abnormal

Intervention / Treatment
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* Behavioral: mHealth application (custom)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional Model Description: Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Feasibility (Task Completion) | Number of interaction trials completed (measured as whole number count, per subject, per week) | Weekly, for 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Task Performance | Baseline (Enrollment) and Postintervention (Week 8) | Weekly, for 8 weeks | 
| Usability Rating | DFS UX survey (assessed by Likert scale, 1-5 whole number response per question) | Once, at 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition