Schizophrenia Clinical Trial
Official title:
Using mHealth to Optimize Pharmacotherapy Regimens
Verified date | April 2024 |
Source | New York State Psychiatric Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | January 20, 2023 |
Est. primary completion date | December 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years to 30 Years |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Bestself Behavioral Health, Inc. | Buffalo | New York |
United States | Institute for Family Health | New York | New York |
United States | Lenox Hill Hospital | New York | New York |
United States | Washington Heights Community Service | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | BestSelf Behavioral Health, National Institute of Mental Health (NIMH), New York State Psychiatric Institute, Washington Heights Community Service, Northwell Health, Early Treatment Program at Lenox Hill, The Institute for Family Health Center for Counseling at Walton |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change of Treatment Satisfaction Questionnaire for Medication (TQSM) from baseline to 6 months | The TSQM assesses client satisfaction with medication. It comprises 14 items across four domains focusing on effectiveness (3 items), side effects (5 items), convenience (3 items), and global satisfaction (3 items) of the medication over the previous 2-3 weeks, or since the patient's last use. With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied).The 7-item scales had a non-neutral midpoint, such that there were more positive response options than negative response options, to allow for precise information to be obtained at the upper end of the score distribution. Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100. Item 4 was not included for scoring. If an item score is missing and half of the items in the domain are complete, domain scores may be imputed from the person-specific mean score of completed items. | baseline to 6 months | |
Primary | change of Client Satisfaction Questionnaire (CSQ-8) from baseline to 6 months | 8-item easily scored and administered measurement that is designed to measure client satisfaction with services. The overall score is produced by summing all item responses. Scores range from 8 to 32, with higher values indicating higher satisfaction. | baseline to 6 months |
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