Healthy VolunteersNCT02693275
Reference Database Development for the Quotient® System iPad Test
A study testing Quotient® System iPad Test in people with Healthy Volunteers, run by Pearson/Clinical Assessment at 4 sites in United States.
Trial summary
This study is being conducted to create a database for the Quotient® System iPad Test. Using community sampling, NCS Pearson will compile the results of this study to create a database against which the results of clinical Quotient tests may be compared to determine patient performance relative to the expected results… Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Quotient® System iPad Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,333 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Male or Female
- Ages 6 years - 79 years and 11 months (79.11) of age
- Report of good physical health
- Able to understand test instructions and comply with testing
- Willing to give written informed consent and/or assent
Who cannot join
- History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, seizure disorders). History of febrile seizure does not exclude subject from study participation
- Major Medical Disorders known to the Investigator that would make it difficult for the participant to complete study requirements
- Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
- Currently ill with cold, flu or infections which may compromise their ability to perform the computer task
- Any condition in which the investigator deems the subject inappropriate for participation in the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Erickson Research and Development
Clinton, Utah, 84015
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Tanner Clinic
Layton, Utah, 84041
Growing Child Pediatrics, PA
Raleigh, North Carolina, 27615
About this study
Official title: Reference Database Development for the Quotient® System iPad Test (Ages 6 - 80 Years Old)
This study is being conducted to create a database for the Quotient® System iPad Test. Using community sampling, NCS Pearson will compile the results of this study to create a database against which the results of clinical Quotient tests may be compared to determine patient performance relative to the expected results for developmental age and gender.
Read the detailed description
Study Design:
This study is being conducted at 4 clinical sites and consists of up to two study visits. All study participants will complete at least one study visit. A smaller cohort of participants will complete a second visit for the purpose of assessing test retest reliability across the study sample. Subjects will be recruited using the clinic's relevant patient population and IRB approved recruitment material. Interested volunteers will participate in an initial screening, which may be done by telephone or in person that will be conducted by the clinic's research staff. Upon preliminary confirmation that the subject meets all inclusion criteria and does not meet any exclusion criteria, an appointment will be scheduled for the first study visit.
At the first visit, the study will be explained in detail. Adults will be asked to provide written informed consent. Parents or guardians of individuals under the age of 18 years old will provide written informed consent on behalf of the minor. Individuals between the age of 7 and 18 years of age will also provide their written assent. All consents and assents will be obtained prior to any study procedure being performed. Following consent, a brief medical history, including current medications the subject is taking, will be obtained. Subjects will complete a standard self-assessment questionnaire, appropriate for age, to screen for presence of ADHD. Subjects will not be excluded from the study based on responses to the questionnaire but their results will be considered in the analysis of study data. All subjects will take the appropriate version; Child (ages 6 -12.11), Adolescent (ages 13 - 19.11), or Adult (ages 20 - 79.11) of the 15-minute Quotient® System iPad Test.
At this visit, a cohort of participants across 7 age groups will be asked to return the clinic for a second study visit. These participants will be asked, in consecutive order of enrollment, to return to the clinic for a second study visit. Study participants who complete visit one are not required to participate in the retest cohort group and may opt out of returning to the clinic for visit two. Once the required number of participants (350 - 400) have completed the second study visit, that portion of the study will be closed to further enrollment and no further subjects will be given the option to return for the retest visit (visit 2).
Retest Visit 2 will occur 7 - 14 days following study visit 1. Subjects will be assessed for changes in health status and current medications since the time of visit 1. Subjects will repeat the appropriate version (Child, Adolescent or Adult) of the 15-minute Quotient® System iPad Test.
● Study Enrollment: A minimum of 1440 subjects with oversampling of 11%. Total enrollment is expected to be approximately 1600.
● Study Population:
Visit 1:
Male and female subjects from the age of 6 years until the age of 80 years. There will be a total of 16 age bands with approximately 90 subjects enrolled in each age band. Optimally, there will be a 50-50-male/female-gender stratification per each age category.
Visit 2:
A cohort of at least 350 subjects who have completed study Visit 1 will be asked to return for Visit 2. An oversampling of 11% is anticipated bringing the total number of subjects asked to return for Visit 2 to approximately 400. Visit 2 will include both male and female participants from 7 age bands.
- Study Procedures:
- Review Inclusion/Exclusion Criteria
- Obtain Written Adult Informed Consent
- Obtain Written Minor Informed Assent
- Verbal Report of Medical History
- Concomitant Medications
- Self-assessment Questionnaire:
- ADHD Self Rating Scale (ADHDRS-IV) for subjects ages 6 - 19.11
- ADHD Symptom Rating Scale (ASRS-V1.1) for subjects ages 20 - 79.11
- Quotient® System iPad Test - Child, Adolescent or Adult test as appropriate for age
- Study Duration:
Dependent on accrual but estimated to be six (6) months to nine (9) months.
● Statistical Analysis Plan: The data of the study will be used to identify normative ranges and percentiles by age and gender. Each age range group of 90 will be compared for group differences between genders, and evaluated for the effects of age on performance. The SPSS software (SPSS Inc., Chicago, Illinois) will be used for statistic procedures in this study.
- Conditions
- Healthy Volunteers
- Being tested
- Quotient® System iPad Test
- Keywords
- Community Sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quotient® System iPad TestDevice
Also called Quotient®
See arm/group description
| Study group | Role | What they receive |
|---|---|---|
| Quotient® System iPad Test | Other | The Quotient® System iPad Test is a test specifically designed to provide clinicians with objective measures in ability to maintain seated stillness, sustained attention to a monotonous task and inhibiting incorrect impulsive responses. The attention task with motion analyses provides a number of objective measures for detailed assessment of the subject's movements and attentiveness. Receives: Device: Quotient® System iPad Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of measured head motion of typically developing subjects while taking the attention test as determined on the dimensions of total number of motions >1mm/sec during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Duration of motion free periods in seconds during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Area of head motion covered in centimeters during the total 15-minute test.
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Total length of movement in meters during the total 15-minute test.
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Range of attentive responses to a 15-minute go/no-go attention task (assessed simultaneously with the motion assessment) in terms of accuracy in % correct response during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Average response time to stimulus items in milliseconds during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Total errors of omission in % of total targets during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Total errors of commission in % of total non-targets during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Variability reported as the standard deviation of all responses from mean response time reported in milliseconds during the 15-minute test
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startApr 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pearson/Clinical Assessment
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Calvin R Sumner, MD, Principal investigator, Pearson/Clinical Assessment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693275
- Sponsor's protocol ID
- PNB&I-4001
- Status last verified
- Apr 2017
- First submitted
- 23 Feb 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reference Database Development for the Quotient® System iPad Test (Ages 6 - 80 Years Old)
- ClinicalTrials.gov ID
- NCT02693275
- Acronym / sponsor ID
- PNB&I-4001
- Conditions
- Healthy Volunteers
- Keywords
- Community Sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,333 participants (actual)
- Lead sponsor
- Pearson/Clinical AssessmentIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to create a database for the Quotient® System iPad Test. Using community sampling, NCS Pearson will compile the results of this study to create a database against which the results of clinical Quotient tests may be compared to determine patient performance relative to the expected results for developmental age and gender.
Detailed description
Study Design:
This study is being conducted at 4 clinical sites and consists of up to two study visits. All study participants will complete at least one study visit. A smaller cohort of participants will complete a second visit for the purpose of assessing test retest reliability across the study sample. Subjects will be recruited using the clinic's relevant patient population and IRB approved recruitment material. Interested volunteers will participate in an initial screening, which may be done by telephone or in person that will be conducted by the clinic's research staff. Upon preliminary confirmation that the subject meets all inclusion criteria and does not meet any exclusion criteria, an appointment will be scheduled for the first study visit.
At the first visit, the study will be explained in detail. Adults will be asked to provide written informed consent. Parents or guardians of individuals under the age of 18 years old will provide written informed consent on behalf of the minor. Individuals between the age of 7 and 18 years of age will also provide their written assent. All consents and assents will be obtained prior to any study procedure being performed. Following consent, a brief medical history, including current medications the subject is taking, will be obtained. Subjects will complete a standard self-assessment questionnaire, appropriate for age, to screen for presence of ADHD. Subjects will not be excluded from the study based on responses to the questionnaire but their results will be considered in the analysis of study data. All subjects will take the appropriate version; Child (ages 6 -12.11), Adolescent (ages 13 - 19.11), or Adult (ages 20 - 79.11) of the 15-minute Quotient® System iPad Test.
At this visit, a cohort of participants across 7 age groups will be asked to return the clinic for a second study visit. These participants will be asked, in consecutive order of enrollment, to return to the clinic for a second study visit. Study participants who complete visit one are not required to participate in the retest cohort group and may opt out of returning to the clinic for visit two. Once the required number of participants (350 - 400) have completed the second study visit, that portion of the study will be closed to further enrollment and no further subjects will be given the option to return for the retest visit (visit 2).
Retest Visit 2 will occur 7 - 14 days following study visit 1. Subjects will be assessed for changes in health status and current medications since the time of visit 1. Subjects will repeat the appropriate version (Child, Adolescent or Adult) of the 15-minute Quotient® System iPad Test.
● Study Enrollment: A minimum of 1440 subjects with oversampling of 11%. Total enrollment is expected to be approximately 1600.
● Study Population:
Visit 1:
Male and female subjects from the age of 6 years until the age of 80 years. There will be a total of 16 age bands with approximately 90 subjects enrolled in each age band. Optimally, there will be a 50-50-male/female-gender stratification per each age category.
Visit 2:
A cohort of at least 350 subjects who have completed study Visit 1 will be asked to return for Visit 2. An oversampling of 11% is anticipated bringing the total number of subjects asked to return for Visit 2 to approximately 400. Visit 2 will include both male and female participants from 7 age bands.
- Study Procedures:
- Review Inclusion/Exclusion Criteria
- Obtain Written Adult Informed Consent
- Obtain Written Minor Informed Assent
- Verbal Report of Medical History
- Concomitant Medications
- Self-assessment Questionnaire:
- ADHD Self Rating Scale (ADHDRS-IV) for subjects ages 6 - 19.11
- ADHD Symptom Rating Scale (ASRS-V1.1) for subjects ages 20 - 79.11
- Quotient® System iPad Test - Child, Adolescent or Adult test as appropriate for age
- Study Duration:
Dependent on accrual but estimated to be six (6) months to nine (9) months.
● Statistical Analysis Plan: The data of the study will be used to identify normative ranges and percentiles by age and gender. Each age range group of 90 will be compared for group differences between genders, and evaluated for the effects of age on performance. The SPSS software (SPSS Inc., Chicago, Illinois) will be used for statistic procedures in this study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quotient® System iPad Test | Other | Device: Quotient® System iPad TestThe Quotient® System iPad Test is a test specifically designed to provide clinicians with objective measures in ability to maintain seated stillness, sustained attention to a monotonous task and inhibiting incorrect impulsive responses. The attention task with motion analyses provides a number of objective measures for detailed assessment of the subject's movements and attentiveness. |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female
- Ages 6 years - 79 years and 11 months (79.11) of age
- Report of good physical health
- Able to understand test instructions and comply with testing
- Willing to give written informed consent and/or assent
Key exclusion criteria (5 listed)
- History of known neurological disease or insult (e.g., head trauma with LOC, skull fracture, seizure disorders). History of febrile seizure does not exclude subject from study participation
- Major Medical Disorders known to the Investigator that would make it difficult for the participant to complete study requirements
- Any major medical or neurological condition that could affect motor activity or attention (e.g. Parkinson's, MS, dementia)
- Currently ill with cold, flu or infections which may compromise their ability to perform the computer task
- Any condition in which the investigator deems the subject inappropriate for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quotient® System iPad TestAlso: Quotient®See arm/group description | Device | Quotient® System iPad Test |
Primary outcome
Range of measured head motion of typically developing subjects while taking the attention test as determined on the dimensions of total number of motions >1mm/sec during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Duration of motion free periods in seconds during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Area of head motion covered in centimeters during the total 15-minute test.
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Total length of movement in meters during the total 15-minute test.
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Range of attentive responses to a 15-minute go/no-go attention task (assessed simultaneously with the motion assessment) in terms of accuracy in % correct response during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Average response time to stimulus items in milliseconds during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Total errors of omission in % of total targets during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Total errors of commission in % of total non-targets during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Variability reported as the standard deviation of all responses from mean response time reported in milliseconds during the 15-minute test
Time frame: 12 Months
The result of this primary outcome measure will be analyzed statistically to establish the range of measured values for this assessment parameter and the population distribution of the measurement in typically developing subjects stratified for age, gender and ethnicity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Calvin R Sumner, MD principal investigator
Pearson/Clinical Assessment
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quotient® System iPad Test in people with Healthy Volunteers, run by Pearson/Clinical Assessment at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of measured head motion of typically developing subjects while taking the attention test as determined on the dimensions of total number of motions >1mm/sec during the 15-minute test (time frame: 12 Months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017; AzTrials last refreshed its copy on 28 Oct 2026.