Cognitive Function Abnormal
Conditions
Keywords
Cognition
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 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.
Interventions
BEHAVIORALmHealth application (custom)
Smartphone based application designed to engage user executive functions
Sponsors
Kansas State University
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
NXTech
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Task Completion Rate | At 8 weeks | Percentage of participants completing minimum required weekly interactions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Task Performance | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognition Exercises Group I Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions
mHealth application (custom): Smartphone based application designed to engage user executive functions | 64 |
| Cognition Exercises Group C Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions
mHealth application (custom): Smartphone based application designed to engage user executive functions | 60 |
| Total | 124 |
Baseline characteristics
| Characteristic | Cognition Exercises Group I | Cognition Exercises Group C | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 60 Participants | 123 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Black / African American | 6 Participants | 4 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants | 9 Participants | 15 Participants |
| Race/Ethnicity, Customized Unreported | 7 Participants | 4 Participants | 11 Participants |
| Race/Ethnicity, Customized White | 41 Participants | 36 Participants | 77 Participants |
| Region of Enrollment United States | 64 Participants | 60 Participants | 124 Participants |
| Sex/Gender, Customized Female | 37 Participants | 29 Participants | 66 Participants |
| Sex/Gender, Customized Male | 17 Participants | 26 Participants | 43 Participants |
| Sex/Gender, Customized Not Reported | 7 Participants | 4 Participants | 11 Participants |
| Sex/Gender, Customized Transgender Male or Transgender Female | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 0 / 60 |
| other Total, other adverse events | 0 / 64 | 0 / 60 |
| serious Total, serious adverse events | 0 / 64 | 0 / 60 |
Outcome results
Primary
Task Completion Rate
Percentage of participants completing minimum required weekly interactions
Time frame: At 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognition Exercises Group I | Task Completion Rate | 66 Percentage of eligible participants | Standard Deviation 15 |
| Cognition Exercises Group C | Task Completion Rate | 57 Percentage of eligible participants | Standard Deviation 19 |
Secondary
Change in Task Performance
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
Time frame: At 8 weeks
Population: Subgroup of participants in each arm completing all study weeks and requested activities, were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognition Exercises Group I | Change in Task Performance | 0.62 units on a scale | Standard Error 0.03 |
| Cognition Exercises Group C | Change in Task Performance | 0.62 units on a scale | Standard Error 0.04 |