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| ID | Type | Description | Link |
|---|---|---|---|
| R43DA051270 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Kansas State University | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognition exercises group I | Experimental | Subjects enrolled in this arm are exposed to an active task intervention designed for higher cognitive effort training functions |
|
| Cognition exercises group C | Active Comparator | Subjects enrolled in this arm are exposed to an active task intervention designed for lower cognitive effort training functions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth application (custom) | Behavioral | Smartphone based application designed to engage user executive functions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Task Completion Rate | Percentage of participants completing minimum required weekly interactions | At 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | At 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Travis Smith | Kansas State | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kansas State DPS | Manhattan | Kansas | 66506 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Units are participants are population is same as assignment in Participant Flow
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Cognition Exercises Group C |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Task Completion Rate | Percentage of participants completing minimum required weekly interactions | Posted | Mean | Standard Deviation | Percentage of eligible participants | At 8 weeks |
|
2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Kansas State | (785) 532-6850 | external+studydirector@nxtech.co |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 17, 2022 | Dec 15, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 17, 2022 | Dec 15, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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Between subjects and within subjects mixed design, reflecting major variables of high/low group intervention/control.
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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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
|
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| 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 | Subgroup of participants in each arm completing all study weeks and requested activities, were analyzed | Posted | Mean | Standard Error | units on a scale | At 8 weeks |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | 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 | 0 | 60 | 0 | 60 | 0 | 60 |
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