An Investigational Study Examining the Efficacy of QbMobile in Treatment Monitoring in Individuals With ADHD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: observational study.
- Who it may be relevant to
- Registry conditions: Attention Deficit Disorder With Hyperactivity (ADHD), Attention Deficit Disorder (ADD). Basic parameters: 6 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The current study will investigate if QbMobile can be used to improve the accuracy and objective identification of reduced ADHD symptoms in tests scores once treatment has been initiated.
Detailed description
This 4-week study will evaluate QbMobile's performance in monitoring ADHD treatment response. Participants will complete the 10-minute QbMobile test on their personal device during a scheduled clinical visit. They will then repeat the test remotely the following day before beginning their ADHD medication treatment. At week 2 and week 4, participants will take QbMobile remotely at least 1 hour after taking their ADHD medication and no longer than 4 hours post dose.
Interventions
- Other observational study
observational study
Primary outcome measures
- Change in QbMobile Total Score from Baseline at Visit 3 and Visit 4 [Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)]
Secondary outcome measures (1)
- Change in QbMobile SD-scores from Baseline at Visit 3 and Visit 4 [Time frame: Baseline, Visit 3 (Week 2), and Visit 4 (Week 4)]
Eligibility criteria
Inclusion criteria
- Provide written informed consent (including parent/legal guardians consent when this is required for individuals under 18 years old and assent as is required based on the age of participant) for QbMobile;
- Aged > 6 years and < 60 years old;
- Referred for an ADHD assessment or has a diagnosis of ADHD but not currently receiving any type of stimulant or nonstimulant medication treatment;
- Meets DSM-5 or ICD-11 criteria for a primary diagnosis of ADHD (combined, inattentive, or hyperactivity/impulsive presentation) per sites standard clinical care evaluation;
- Qbtech Rating Scale total score of >24 at Visit 1;
- Have adequate sensory and physical ability to complete QbMobile;
- Possess or has access to an iPhone model that supports QbMobile.
Exclusion criteria
- Intellectual disability designated by IQ<75);
- Has used psychostimulant medication within 7 days prior to Visit 1;
- A concurrent medical diagnosis that could significantly affect test performance (brain injuries, Parkinson's disease, current epilepsy or active seizures, amyotrophic lateral sclerosis (ALS), multiple sclerosis, dementias (e.g., vascular dementia, Alzheimer disease, etc);
- Other conditions that could affect test performance (migraine or other types of severe headache, chronic or acute pain);
- Substance use (e.g., alcohol, drugs) that may affect performance on the day of the test.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 7 centers
- Focus-MD — Mobile
- Prodigy Psychiatric Group — San Jose
- Bokhari Medical Consortium — Largo
- CCM Clinical Research Group — Miami
- Nona Pediatric Center — Orlando
- Godwin Psychiatry — Goldsboro
- MindWell Urgent Care — Dallas
Identifiers
NCT: NCT07217977 · 00082513/QB24-02