Using mHealth to Optimize Pharmacotherapy Regimens (NCT04248517) | Clinical Trial Compass
CompletedNot Applicable
Using mHealth to Optimize Pharmacotherapy Regimens
United States23 participantsStarted 2020-10-09
Plain-language summary
This project will use a smartphone technology to improve medication prescribing for individuals with FEP. We will collect real-time symptom and functioning data via smartphones to provide prescribers and other clinical team members with clinically relevant and time-sensitive information that will inform and promote shared decision making (SDM) and personalized interventions. The result will be a time-sensitive, data-driven, collaborative process to optimize medication regimens in order to maximize benefits, minimize harms, and promote adherence.
Data collection for NCT04248517 (Using mHealth to Optimize Pharmacotherapy Regimens) was completed in December 2023. Data analysis was underway when human subjects research at NYSPI was suspended on June 23, 2023 and thus study results are not available to be posted. The team will post results as soon as possible.
Who can participate
Age range
16 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female OnTrackNY participants, ages 16 to 30, of any race/ethnicity
* Able and willing to give informed consent and participate in the intervention
* Participating in OnTrackNY for less than 1 year because this group may be more in need of medication adjustments and will be less likely to graduate from the program before 6 months of participation.
Exclusion Criteria:
* Suicidal at baseline with C-SSRS score 4 or 5.
* PANSS baseline score of 5 (moderately severe) or greater on the Conceptual Disorganization item (P2)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months
Timeframe: baseline to 6 months
2
change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months