AI-Powered Medication Adherence App for First Episode Psychosis

Recruiting at 4 trial locations

Overseen By Cristina Gonzalez, MS

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwell Health

Must be taking: Antipsychotics

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app that uses artificial intelligence (AI) to help people with first episode psychosis adhere to their medication routines. The main goal is to determine if the app improves medication adherence compared to the usual care provided at treatment centers. Participants must be enrolled in a Coordinated Specialty Care (CSC) program and taking an oral antipsychotic medication. Those who meet these criteria may find that joining the trial offers extra support in managing their treatment. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, providing an opportunity to gain additional insights into its use.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it seems you need to be on an oral antipsychotic to participate.

What is the safety track record for these treatments?

Research shows that smartphone apps are popular with patients experiencing their first episode of psychosis. One study found these apps useful and acceptable for monitoring patients. Other studies indicate that apps using artificial intelligence (AI) can accurately verify if patients take their medication as prescribed by using the phone's camera to confirm medication use.

These apps extend beyond medication management; they also help patients better understand their treatment. While studies do not mention any negative effects, the technology in these apps is generally well-tolerated. This suggests that using an AI-powered app to assist with medication adherence is considered safe based on current research. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the AI-powered medication adherence app for first episode psychosis because it uses artificial intelligence to enhance how patients stick to their medication schedules. Unlike traditional treatments, which often rely on manual reminders or simple pill organizers, this app provides personalized support by analyzing user behavior and offering tailored reminders and interventions. This innovative approach not only helps improve adherence but also empowers patients with real-time insights and feedback, potentially leading to better health outcomes.

What evidence suggests that this app is effective for medication adherence in first episode psychosis?

Research has shown that smartphone apps can help individuals with conditions like schizophrenia adhere to their medication schedules. In this trial, participants may use a smartphone app designed to support medication adherence. One study found that an app called MedAdhere helped patients with schizophrenia take their medications more accurately. Another app, AiCure, uses smartphone cameras to verify medication intake and track doses. These apps employ smart technology to ensure patients receive accurate medication information. While research continues, these apps appear promising in preventing relapses, when symptoms return, in people with psychosis. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals enrolled in a Coordinated Specialty Care (CSC) program who have been prescribed an oral antipsychotic medication to manage conditions like psychosis or first episode psychosis. There are no specific exclusion criteria, so it's open to anyone meeting the inclusion requirements.

Inclusion Criteria

I am taking an oral antipsychotic medication.

Enrolled in a CSC program

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use an AI smartphone app to support medication adherence or receive usual care

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smartphone App
• Usual Care

Trial Overview The study is testing an artificial intelligence-powered smartphone app designed to help patients with their adherence to taking oral antipsychotic medications regularly as compared to the usual care without such technological support.

How Is the Trial Designed?

Group I: Smartphone App Experimental Treatment 1 Intervention

artificial intelligence (AI) smartphone app to provide support for medication adherence

Group II: Usual Care Active Control 1 Intervention

Usual care provided at CSC clinic

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials

481

Recruited

470,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10727482/

Efficacy of a Smartphone App in Enhancing Medication ... This study aimed to explore the effectiveness of a smartphone app (MedAdhere) on medication adherence and accuracy among patients with schizophrenia.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0920996424004857

AI-based medication adherence prediction in patients with ... The AiCure app allows remote confirmation of patient medication ingestion using smartphone cameras, providing continuous measurement of dosing events. This app ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7683257/

Artificial Intelligence–Powered Smartphone App to Facilitate ... Utilizing advanced machine learning algorithms, smartphone apps have the potential to improve medication information delivery to patients.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03558529

Feasibility and Acceptability of a Smartphone App to ... There is growing evidence that interventions monitoring 'early signs' can be effective in preventing relapses of psychosis. Such interventions work on the ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/9/3/e025823

App to support Recovery in Early Intervention Services ... Although emerging research suggests that Smartphone apps hold promise in delivering effective interventions to adults with psychosis, the evidence base is under ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380402/

Smartphone-Based Self-Monitoring in First Episode Psychosis Our study suggests that smartphone-based technologies are an acceptable monitoring tool for patients with first episode of psychosis. While ...

7. psychiatryonline.org psychiatryonline.org/doi/10.1176/appi.focus.20250014

Smartphone Apps and Digital Tools for Managing ... 39. Zhu Z, Roy D, Feng S, et al: AI-based medication adherence prediction in patients with schizophrenia and attenuated psychotic disorders.

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04046497/artificial-intelligence-to-measure-adherence-to-oral-medication

Artificial Intelligence to Measure Adherence to Oral ... The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients ...