Ignite Creation Date:
2024-05-06 @ 1:34 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04061642
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2019-08-05
Brief Title:
A Feasibility Study of an AI-Powered Clinical Decision Aid for Personalized Depression Treatment Selection
Sponsor:
Aifred Health Inc
Organization:
Aifred Health Inc
Study Overview
Official Title:
A Feasibility Study of a Hybrid-ClassicDeep-Learning Enabled Clinical Decision Aid for Personalized and Individualized Pharmacological Depression Treatment Selection
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Clinical Decision Aid CDA is a predictive model that takes as input individual patient characteristics called features which are inputted by the physician or by patient self-report and outputs a list of possible treatments with each treatment associated with a predicted efficacy likelihood to achieve response and likelihood to achieve remission each expressed as a percentage The treatments which may include any approved treatment for depression will be presented to the physician who will then make a treatment choice
Detailed Description:
Hypothesis 1 There will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and CDA
Hypothesis 2 Physicians will not subjectively report that using the CDA and study software increased the length of their appointments
Hypothesis 3 At least 66 of patients and 66 of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale with higher ratings indicating greater trust
Hypothesis 4 At least 66 of patients and 66 of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale with higher ratings indicating greater usability
Hypothesis 5 At least 70 of physicians and 65 of patients will still be using the application regularly by the end of the study For physicians regularly will be defined as the application being used in every study-related visit For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week
Exploratory hypothesis Based on our machine learning results to date we expect between 40-50 of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks This is exploratory and the study is not necessarily powered to demonstrate this
Hypothesis 2 Physicians will not subjectively report that using the CDA and study software increased the length of their appointments
Hypothesis 3 At least 66 of patients and 66 of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale with higher ratings indicating greater trust
Hypothesis 4 At least 66 of patients and 66 of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale with higher ratings indicating greater usability
Hypothesis 5 At least 70 of physicians and 65 of patients will still be using the application regularly by the end of the study For physicians regularly will be defined as the application being used in every study-related visit For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week
Exploratory hypothesis Based on our machine learning results to date we expect between 40-50 of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks This is exploratory and the study is not necessarily powered to demonstrate this
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None