Clinical trial NCT04248517: Using mHealth to Optimize Pharmacotherapy Regimens
Official title: Using mHealth to Optimize Pharmacotherapy Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
First-Episode Psychosis
Keywords: mHealth
Schizophrenia
EMA
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Northwell Health, Early Treatment Program at Lenox Hill
name: The Institute for Family Health Center for Counseling at Walton
name: New York State Psychiatric Institute, Washington Heights Community Service
name: BestSelf Behavioral Health
name: National Institute of Mental Health (NIMH)
First posted: 2020-01-30
Enrollment: 23
Sex: ALL
Minimum age (years): 16
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective cohort with comparison group
Primary purpose: OTHER

Brief 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.

Detailed description: Comprehensive early treatment of individuals experiencing schizophrenia has the potential to alter the course of illness and improve long-term outcomes. Psychotropic medications are a critical component of early treatment strategies. First-episode psychosis (FEP) is a critical time to optimize prescribing but evidence suggests that prescribing for this population is suboptimal.

A contributing factor to these difficulties is thought to be the lack of accurate information about the effects of medications on symptoms, their side effects, as well as their behavioral, cognitive, and emotional correlates. At medication management appointments, prescribers typically rely on patients' recollection of how they were doing over periods of weeks. Such retrospective assessments are problematic as they are vulnerable to the influence of memory difficulties, cognitive biases including recency effects and frequency illusions, and reframing. Recent advances in smartphone technologies (mobile Health; mHealth) may help to overcome many of the limitations of retrospective assessments.

This pilot study will be a collaboration with OnTrackNY, an innovative coordinated specialty care (CSC) program for individuals aged 16-30 who are experiencing FEP. OnTrackNY originated as part of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Implementation and Evaluatoin Study. The initial phase of this project will use input from stakeholders including patients, front-line providers, clinical leaders, and members of the research team to adapt and refine the mHealth intervention to improve feasibility and clinical utility. A pilot study at 3 OnTrackNY sites will then examine its feasibility and effectiveness by comparing the management and outcomes of 60 patients randomly assigned to the mHealth application or usual care.

Eligibility criteria: 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)

Primary outcomes:
measure: change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months
timeFrame: baseline to 6 months
measure: change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months
timeFrame: baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Bestself Behavioral Health, Inc.
state: New York
city: New York
country: United States
facility: Washington Heights Community Service
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: Institute for Family Health
state: New York
Study officials:
affiliation: New York State Psychiatric Institute
name: Scott Stroup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stefancic A, Rogers RT, Styke S, Xu X, Buchsbaum R, Nossel I, Cabassa LJ, Stroup TS, Kimhy D. Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. JMIR Ment Health. 2022 Nov 4;9(11):e41482. doi: 10.2196/41482.